Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions Undergoing Single Blastocyst-Stage Embryo Transfer: A Randomised Triple-Blind, Placebo-Controlled Trial

This study aims to evaluate the efficacy of atosiban in patients with previous pregnancy failure and abnormal uterine contractions during the peri-embryo transfer period in assisted reproductive technology. The main questions it aims to answer are:
* Does the use of atosiban in patients with a history of implantation failure and abnormal uterine contractions affect the live birth rate in single blastocyst transfer cycles (fresh or frozen-thawed embryo transfer)?
* Evaluate the differences in efficacy of atosiban regarding perinatal complications and neonatal outcomes, as well as differences in safety concerning miscarriage rates and ectopic pregnancy rates.
Researchers will compare atosiban with placebo (a similar substance containing no active medication) to determine whether atosiban is effective in improving live birth rates from single blastocyst transfer cycles (fresh or frozen-thawed embryo transfer) in patients with a history of implantation failure and abnormal uterine contractions.
* Participants allocated to the Atosiban group will be administered Atosiban (37.5 mg/5 mL, Tractocile®, Ferring Pharma, Geneva, Switzerland) as an intravenous (IV) bolus of 6·75 mg/0.9 mL in 1 minute at 30 minutes prior to the ET procedure, followed by an IV infusion at a rate of 18 mg/h for 1 hour; after 1 hour, the dose of Atosiban will be reduced to 6 mg/h, with a total dose of 37.5 mg. Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration.
* One hour post-embryo transfer, all randomized participants will be invited to have a reevaluation of uterine wave patterns via ultrasound, performed by the same examiner.
* Women who had a clinical pregnancy will be subsequently contacted by nurses to document pregnancy events and outcomes at 12 and 24 weeks of gestation, completion of pregnancy, with a follow-up approximately 6 weeks post-delivery. Those participants who had a negative pregnancy test will not be followed up any further as part of this trial.

Start Date06 Dec 2025

Sponsor / Collaborator

Northwest Women & Children Hospital

NCT07093060

/ RecruitingEarly Phase 1IIT

The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Social Attention in Humans

The main aim of the present study is to investigate whether orally (lingual spray) administered oxytocin influences human social attention and behaviors via oxytocin receptors and whether its effects are dose- and task-dependent.

Start Date09 Jun 2025

Sponsor / Collaborator

University of Electronic Science & Technology of China

CTRI/2024/11/076392

/ Not yet recruitingPhase 3IIT

A Randomized controlled trial to evaluate the efficacy of Atosiban in patients undergoing Embryo transfer. - NIL

Start Date12 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Atosiban acetate

100 Translational Medicine associated with Atosiban acetate

100 Patents (Medical) associated with Atosiban acetate

609

Literatures (Medical) associated with Atosiban acetate

01 Mar 2026·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

Comparative effectiveness of intravenous remifentanil, epidural anesthesia and a two-step analgesic approach for external cephalic version: a large prospective single-center cohort study

Article

Author: Burgos, Jorge ; Quintana, Eider ; Carreras, Marta ; Serna, Rosa María ; Rodríguez, Leire ; Aiartzaguena, Amaia ; Osuna, Carmen ; Centeno, María Del Mar

BACKGROUND:

Among the analgesic strategies used during external cephalic version, neuraxial anesthesia is the only approach that has consistently demonstrated higher vaginal delivery rates. However, neuraxial analgesia encompasses a heterogeneous range of techniques, and higher complication rates have been reported compared with other approaches.

OBJECTIVES:

This study aimed to compare the success of external cephalic version, modes of delivery, maternal pain, and complications using three strategies: intravenous analgesia with remifentanil, epidural anesthesia, and a stepwise approach in which epidural anesthesia was administered only if intravenous analgesia was unsuccessful.

STUDY DESIGN:

We conducted a single-center, consecutive three-phase cohort study including 1963 singleton pregnancies undergoing an external cephalic version: 558 with intravenous remifentanil (Group 1, 2012-2015), 665 with intravenous remifentanil followed by epidural anesthesia 2-3 days later if unsuccessful (Group 2, 2016-2019), and 730 under epidural anesthesia (Group 3, 2020-2024); yielding 2218 procedures, 1233 with intravenous remifentanil and 985 with epidural anesthesia. All procedures followed a standardized protocol, performed or supervised by experienced obstetricians, with continuous presence of anesthesiologists. Ritodrine was administered for tocolysis, or atosiban when contraindicated. Outcomes included success of the external cephalic version, mode of delivery, maternal pain (0-10 numerical scale), any analgesia-related complications, and procedural-related obstetric complications including vaginal bleeding, abnormal fetal heart rate patterns, hospital admission or any event that led to a delivery. Chi-square test was used for comparison, with significance at p<0.05.

RESULTS:

Success rates were highest with epidural anesthesia (70.0%, 511/730), compared with intravenous remifentanil (52.2%, 291/558) and the stepwise approach (65.2%, 440/675; p < 0.001). This was reflected in vaginal delivery rates of 72.2% (526/730), 64.0% (342/534), and 66.1% (444/672), respectively (p = 0.005). Maternal pain was substantially lower under epidural, with 78.3% of women reporting no or minimal pain, whereas this proportion fell to 49.2% in the remifentanil group and to 36.2% in the two-step approach (p < 0.001). Adverse effects of anesthesia were generally uncommon and clinically mild, but higher with epidural anesthesia (p < 0.001). Maternal hypotension was the main complication under epidural anesthesia (16.1%, 159/985), followed by dizziness (3.7%, 36/985), neither associated with significant obstetric clinical consequences. Procedural complications were rare, but more common with epidural anesthesia, and overall, highest among patients undergoing the two-step approach (p = 0.264). Vaginal bleeding occurred in 3.6% (35/985) of epidural cases and 4.3% (53/1233) with remifentanil (p = 0.052). Abnormal fetal heart rate patterns were more frequent with epidural (3.6%, 35/985) than remifentanil (1%, 12/1233) (p < 0.001). Procedure-related hospital admissions were uncommon and similar (3.6%, 35/985, vs 3.6%, 45/1233). Procedure-related deliveries and urgent cesareans were rare, but higher with epidural (1.4%, 15/985) than with remifentanil (0.5%, 6/1233) (p = 0.021).

CONCLUSION:

In this study, a single attempt with epidural anesthesia was the most effective strategy for external cephalic version, achieving the highest success and vaginal delivery rates while providing superior maternal pain control, but with higher complications. These findings may help support more informed counseling and shared decision-making when discussing analgesic options for external cephalic version.

01 Mar 2026·European Journal of Obstetrics & Gynecology and Reproductive Biology

An individual participant data network meta-analysis of the APOSTEL trials on the effect of tocolysis in threatened preterm birth between 30–33+6 weeks of gestation in twin pregnancies

Article

Author: van Kaam, A H ; Pajkrt, E ; Roos, C ; van Gils, L ; Oudijk, M A ; van der Windt, L I

OBJECTIVE:

Twin pregnancies have a substantial risk of preterm birth, but evidence on tocolytics is limited. We evaluated whether nifedipine or atosiban improves neonatal outcomes compared with placebo.

DESIGN:

Individual participant data network meta-analysis (IPD-NMA) of two international multicentre randomised controlled trials (APOSTEL 3 and 8).

SETTING:

The APOSTEL-3 compared nifedipine with atosiban, while the APOSTEL-8 compared atosiban with placebo.

POPULATION:

Women with twin pregnancies and threatened preterm birth between 30⁺⁰ and 33⁺⁶ weeks.

METHODS:

Analyses were performed at the infant level using generalised estimating equations to account for clustering within twin pairs.

MAIN OUTCOME MEASURES:

Adverse neonatal outcome: composite of neonatal morbidity or mortality.

RESULTS:

A total of 179 women were included: 94 allocated to atosiban, 27 to nifedipine, and 58 to placebo. Prolongation beyond 48 h was not significantly increased with nifedipine (RR 0.96, 95% CI 0.68-1.36) or atosiban (RR 1.10, 95% CI 0.88-1.38). The composite adverse neonatal outcome occurred in 3.7% of neonates in the nifedipine group (2/54), 7.5% in the atosiban group (14/188), and 5.2% in the placebo group (6/116). Relative risks were 0.72 (95% CI 0.15-3.43) for nifedipine vs placebo, 1.44 (95% CI 0.57-3.64) for atosiban vs placebo, and 2.01 (95% CI 0.47-8.58) for atosiban vs nifedipine.

CONCLUSION:

No clear benefit of nifedipine or atosiban over placebo on neonatal outcomes in twin pregnancies with threatened preterm birth between 30⁺⁰ and 33⁺⁶ weeks was found.

23 Jan 2026·Cureus Journal of Medical Science

Successful Conservative Management After Expulsion Following Fetal Demise in a Triplet Pregnancy: A Case Report

Article

Author: Azoury, Joseph ; Karam, Farah ; Jaalouk, Nour

Triplet pregnancies are associated with high rates of complications, including miscarriage, preterm birth, and selective fetal loss. We present a case of a 42-year-old Caucasian woman with a history of infertility, multiple failed in vitro fertilization (IVF) attempts, and one prior pregnancy loss at 26 weeks of gestation due to placenta previa. She conceived trichorionic triamniotic (TCTA) triplets following intracytoplasmic sperm injection (ICSI) with donor oocytes. At 18 weeks and five days, she developed preterm premature rupture of membranes (PPROM) with umbilical cord prolapse of one fetus, which already had no detectable fetal heart activity. Intrauterine cord ligation (IUCL) was performed, and the demised fetus was retained until expulsion the following day. Conservative management with progesterone support, antibiotics, anticoagulation, tocolysis with atosiban (OXTR/V1A oxytocin and vasopressin V1A receptor antagonist), and antihypertensive therapy allowed prolongation of the pregnancy. Despite challenges including intrauterine growth restriction (IUGR), hypertension, hypothyroidism, and anemia, the remaining two fetuses continued to develop with reassuring Doppler ultrasonography (DUS) findings. At 33 weeks and two days, she underwent urgent cesarean delivery of two viable preterm infants for non-reassuring fetal heart rates (FHRs). This case highlights that with individualized management and intensive monitoring, continuation of pregnancy after selective fetal loss in a triplet gestation is possible, improving neonatal outcomes.

News (Medical) associated with Atosiban acetate

22 Nov 2022

·www.biospace.com

XOMA Acquires Royalty and Milestone License to Ebopiprant, a Preterm Labor Asset, Being Developed by Organon

XOMA assumes the rights to ebopiprant from ObsEva, including the Organon License, Patent Estate, and Merck KGaA, Darmstadt, Germany, license, for a $15 million outlay Potential to earn $475 million in development, regulatory, and sales milestones Low- to mid- teens royalties upon commercialization Expands XOMA’s portfolio into new therapeutic segment – women’s health EMERYVILLE, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, announced today it has acquired all rights and title to ebopiprant held by ObsEva for $15 million plus certain earn-out payments. XOMA has assumed the ebopiprant intellectual property (IP) estate and all license agreements, including the 2021 exclusive license agreement from ObsEva to Organon related to the development and commercialization of ebopiprant. “We are very pleased to add ebopiprant to XOMA’s royalty and milestone portfolio. Preterm labor is extremely stressful for expectant parents and their families. The costs to care for premature babies can quickly escalate to hundreds of thousands of dollars, resulting in long-term financial distress for many families,” stated Jim Neal, Chairman and Chief Executive Officer of XOMA. “The economics in the ebopiprant license acquisition have the potential to deliver significant returns to XOMA and our stockholders from the clinical development milestones alone. We wish Organon, a global women’s health company, success in its development activities with ebopiprant.” Under the terms of the agreement, XOMA has acquired all rights to ebopiprant held by ObsEva, including the Organon/ObsEva license agreement and the IP associated with the asset. XOMA will now be entitled to receive up to $475 million in development, regulatory, and sales-based milestone payments under the ObsEva/Organon license agreement. XOMA will pay to ObsEva a portion of the development and regulatory milestones, as well as certain sales milestones, up to $98 million. Upon commercialization, XOMA will receive royalties that range from low- to mid-teens from Organon and will make a mid-single-digit royalty payment to Merck KGaA, Darmstadt, Germany. About Ebopiprant Ebopiprant (OBE022) was licensed by ObsEva from Merck KGaA, Darmstadt, Germany, in 2015. ObsEva previously announced positive results from PROLONG Part B, a 113-patient Phase 2a proof-of-concept, randomized, double-blind, placebo-controlled trial in women experiencing spontaneous preterm labor that compared atosiban (ex-U.S. standard of care) plus ebopiprant versus atosiban plus placebo for 7 days. In the study, ebopiprant plus atosiban reduced delivery in singleton pregnancies at 48 hours after the start of dosing by 55% compared to atosiban plus placebo. Overall, 12.5% of women receiving ebopiprant plus atosiban delivered within 48 hours of starting treatment compared to 21.8% receiving atosiban plus placebo (OR 90% CI: 0.52 (0.22, 1.23)). The incidence of maternal, fetal, and neonatal adverse events were comparable between both the ebopiprant and placebo groups. About XOMA Corporation XOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio with more than 70 assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to ebopiprant, the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time, and XOMA’s cash sufficiency forecast. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except Vabysmo®, are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor Contact XOMA Media Contact Juliane Snowden Kathy Vincent XOMA Corporation KV Consulting & Management +1 646-438-9754 +1 310-403-8951 juliane.snowden@xoma.com kathy@kathyvincent.com

Clinical ResultLicense out/in

30 Jul 2021

·endpts.com

Merck's women's health spinout snags mid-stage candidate for preterm birth; Keytruda nails down TNBC approval after March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal. Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions. “This development-stage asset is being studied in one of the most crucial unmet needs for women globally,” Organon CEO Kevin Ali said in a statement. There are currently no approved drugs for the acute treatment of preterm labor in the US. Back in November, ObsEva said ebopiprant reduced the delivery of pregnancies (not including twin pregnancies) by 55% at 48 hours when administered with atosiban (the ex-US standard of care), compared to atosiban alone. Overall, 12.5% of women in the treatment arm delivered babies within 48 hours of starting treatment, compared to 21.8% in the placebo arm, ObsEva said of the Phase IIa trial. “The incidence of maternal, fetal and neonatal adverse events were comparable between subjects in the ebopiprant group and the placebo group,” the company said. Organon officially spun out from Merck on June 3 with a portfolio of more than 60 medicines, including Nexplanon, its long-active reversible contraceptive. Nexplanon is one of the top hormonal contraceptives in the country, according to IQVIA data, and grew at an annual compound growth rate of 9% between 2014 and 2019. — Nicole DeFeudis Keytruda nails down TNBC approval after March CRL Merck’s blockbuster checkpoint inhibitor Keytruda has won another FDA approval, this time in a line of triple-negative breast cancer. Regulators handed down the greenlight for the treatment of patients with high-risk early-stage TNBC in combination with chemo, as neoadjuvant and then continued as a single agent as adjuvant treatment after surgery. The thumbs up marks the 30th indication for which the Keytruda is approved in the US, Merck said. Additionally, the FDA converted the Keytruda-chemo combo accelerated approval in locally recurrent unresectable or metastatic TNBC for tumors expressing PD-L1 to full approval. The TNBC approval comes after the FDA handed Merck a rare CRL for Keytruda back in March, after an adcomm unanimously voted to recommend waiting for more data for the study in question. Advisers and regulators pointed toward concerns over the trial’s event-free survival primary endpoint over placebo, saying researchers hadn’t watched patients long enough after treatment to determine EFS and OS. But a few weeks later, Merck claimed a win in the study after claiming it reached the interim analysis checkpoint. The trial, known as KEYNOTE-522, met its dual primary endpoints of event-free survival and pathological complete response. — Max Gelman

CollaborateAccelerated Approval

27 Jul 2021

·www.pharmatimes.com

Organon and ObsEva to collaborate on preterm labour treatment

Women’s health company Organon has signed a license agreement with Swiss biopharma company ObsEva to develop a potential treatment for preterm labour. Under the terms of the agreement, Organon will license the global development, manufacturing and commercial rights to ebopiprant, an investigational selective prostaglandin F2α (PGF2α) receptor antagonist. Ebopiprant is being evaluated for the treatment for preterm labour by reducing inflammation and uterine contraction – if approved, it has the potential to be a first-in-class therapy for the condition in the US. ObsEva will receive tiered double-digit royalties on commercial sales of ebopiprant as well as up to $500m in upfront and milestone payments. This includes $25m to be paid upon signing of the deal, up to a further $90m in development and regulatory milestones and up to $385m in sales-based milestones. Last year, ObsEva announced positive results from a Phase IIa trial of ebopiprant in preterm labour. In this trial, the PGF2α receptor agonist reduced delivery in singleton pregnancies at 48 hours after the start of dosing by 55% compared to atosiban, the ex-US standard of care treatment for preterm labour. Overall, 12.5% of women receiving ebopiprant delivered within 48 hours of starting treatment compared to 21.8% on placebo. In singleton pregnancies, 12.5% of women receiving ebopiprant treatment delivered with 48 jours compared to 26.8% in the placebo group. “This development-stage asset is being studied in one of the most crucial unmet needs for women globally. As we build Organon’s women’s health research and development portfolio, the agreement strengthens our path to long term growth,” said Kevin Ali, chief executive officer of Organon. “Organon and ObsEva share a commitment to improve the lives of women around the world. Through Organon’s strong development, scientific and medical capabilities, our goal is to change the future for millions of mothers and babies,” he added.

CollaborateFirst in Class

100 Deals associated with Atosiban acetate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Atosiban acetate	G02CX01	DB09059

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Obstetric Labor, Premature	European Union	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	Iceland	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	Liechtenstein	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	Norway	Ferring Pharmaceuticals A/S	20 Jan 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ventricular Fibrillation, Paroxysmal Familial, 1	Phase 2	Belgium	Ferring Pharmaceuticals A/S	01 Nov 2007
Ventricular Fibrillation, Paroxysmal Familial, 1	Phase 2	Czechia	Ferring Pharmaceuticals A/S	01 Nov 2007
Ventricular Fibrillation, Paroxysmal Familial, 1	Phase 2	Spain	Ferring Pharmaceuticals A/S	01 Nov 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02893722 (Pubmed \| Reprod Biol Endocrinol)	Phase 1	-	194	Atosiban	izkgktobgx(jhkbxulalq) = pznnzdeptk zzwmqonywb (hwzcnfpmrt )	-	19 Aug 2022
				Placebo	izkgktobgx(jhkbxulalq) = yrmlkfgknt zzwmqonywb (hwzcnfpmrt )
NCT03570294 (Pubmed \| Oxid Med Cell Longev)	Not Applicable	Obstetric Labor, Premature	56	Atosiban	fldwkbjqac(skkrtecocy) = pkcdasocrt hnjmzxdxfz (xhrqheeyqs ) View more	-	01 Jan 2018
ChiCTR-IOQ-14005715 (Pubmed \| Fertil Steril)	Phase 1	Endometriosis	-	Atosiban treatment	vrpegsrxdv(kycqnxgpsg) = gevxwcatny meowinejfw (ljzwmqbmcl ) View more	-	01 Aug 2016
				atosiban (Control group)	vrpegsrxdv(kycqnxgpsg) = ipxtncprqx meowinejfw (ljzwmqbmcl ) View more
NCT01501214 (Pubmed \| Hum Reprod)	Phase 4	Ventricular Fibrillation, Paroxysmal Familial, 1	800	Atosiban	yefyxhbitp(qtrmpygqoq) = mmmgwkngps tudizilctl (crhpempoxm )	-	01 Dec 2014
				Placebo	yefyxhbitp(qtrmpygqoq) = ijxzjrhgvg tudizilctl (crhpempoxm )
Pubmed \| Reprod Biomed Online	Phase 1	-	71	Atosiban	gnomlxwzba(besuucpxwq) = ahqzchgjau fetqhwuupk (wfcnusjfod ) View more	-	01 Sep 2012

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