Comparison of the efficacy of oral Dydrogesterone with Micronized vaginal Progesterone for luteal phase support in women undergoing In vitro fertilization at the Federal Medical Centre Abuja: a randomized clinical trial

Phase 3

• Conditions: Fertility-female

• Registration Number: PACTR202202641392530
• Lead Sponsor: Researcher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Signed informed consent
Premenopausal females, age = 19 years = 44 years
Non-smokers
Normal follicular phase (Day 2-4) hormones (FSH, LH, E2, PRL, T, and TSH
Documented history of infertility
Normal endovaginal ultrasound at screening
Subject is not pregnant
Clinically indicated protocol for induction of IVF with a fresh embryo
Single or dual embryo transfer
BMI = 18 and = 30 kg/m2

Exclusion Criteria

Evidence of diseases which could limit participation in or completion of the study
Acute urogenital disease
Known allergic reactions to progestogens
Intake of any other experimental drug or on going treatment of any illness
participation in any other clinical trial within 30 days prior to study start
Disability or any condition leading to lack of fitness to participate in or to complete the study
Current or recent substance abuse, including alcohol and tobacco
History of chemotherapy or radiotherapy
Patients with more than 3 unsuccessful IVF attempts
Women in whom pregnancy is contraindicated
Refusal or inability to comply with the requirements of the study protocol for any reason
History of recurrent pregnancy loss

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by endovaginal ultrasound scan

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer;Percentage of Participants With Presence of Fetal Heart Beats at 8 Week's Gestation Determined by endovaginal Ultrasound