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A study to observe the effect of a drug Atosiban in patients undergoing embryo transfer procedure for in vitro fertilization

Effect of Oxytocin receptor antagonist in Embryo transfer recipients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009593
Enrollment
200
Registered
2017-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Primary and Secondary Infertility

Interventions

Intervention1: Atosiban: Atosiban is an oxytocin receptor antagonist.0.9 ml of 6.75mg/ml Atosiban injection is given as an intervenous bolus 30 minutes prior to embryo transfer. An infusion of Atosiba

Sponsors

Infertility Department
Lead Sponsor
Ajanta Hospital IVF Centre
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients >= 23 years of age 2. Body mass index (BMI) of 18.5-38 kg per m2 at screening 3. Normal uterine cavity shown on ultrasound scanning 4. At least one good quality embryo for transfer 5. Basal FSH hormone concentration less than 10 IU/l 6. Patients undergoing IVF-ET using egg donation 7. Patients willing to give written informed consent and willing to comply with the clinical study protocol

Exclusion criteria

Exclusion criteria: 1. Patients >= 45 years of age 2. Uterine abnormalities that could compromise the implantation process (e.g. fibroids, endometrial polyp, uncorrected hydrosalpinges, adenomyosis) 3. Risk of ovarian hyperstimulation syndrome 4. Patients with a known history of hypersensitivity to the study medication 5. Endocrine disorders (uncorrected thyroid disorders, hyperprolactinaemia) 6. Major organ disorders like liver or kidney failure 7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of atosiban in improving the implantation rate (IR) and clinical pregnancy rate (CPR) after embryo transfer.Timepoint: 4 months

Secondary

MeasureTime frame
To evaluate the safety of atosiban in enrolled patients exposed to the drugTimepoint: 4 months

Countries

India

Contacts

Public ContactDr Shweta Shingvi

Ajanta Hospital and IVF Centre

ajantaivf@gmail.com9311003070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026