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

Phase 3

Completed

• Conditions: Health Condition 1: null- Primary and Secondary Infertility

• Registration Number: CTRI/2017/09/009593
• Lead Sponsor: Infertility Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-04-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified