Estradiol and Progesterone Levels Following Frozen Embryo Transfer

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Chorionic Gonadotropin, Alpha; Drug: Estradiol Tablets; Drug: Follitropin Alfa; Drug: Progesterone

• Registration Number: NCT04997525
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief Summary

The aim of the present study is to investigate serum estradiol and progesterone levels in women conceiving after natural, estradiol + progesterone or gonadotropin stimulated frozen embryo transfer (FET) cycles.

Detailed Description

Enrolled women will be randomized based on their ovulation pattern. Ovulatory women will be randomized to either natural cycle or estradiol + progesterone substituted cycle treatment for FET. Anovulatory women will be randomized to either estradiol + progesterone substituted cycle or gonadotropin stimulated cycle treatment for FET.

Included women will undergo blood testing every two weeks for serum estradiol and progesterone levels until gestational age 9+6. Routine vaginal ultrasounds will be performed as well as additional pregnancy ultrasounds.

Secondary obstetric outcomes will be investigated using the womens medical journals.

All the treatments are considered standard treatments for FET.

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-09
• Primary Completion: 2024-05-07
• Status Verified: 2024-12
• Study Completion: 2024-12-06
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 305

Inclusion Criteria

• Age > 18 years < 40 years
• BMI < 35 kg/m2
• Normal wet smear within the past three years
• Thawed blastocysts (day 5 or 6) after either IVF or ICSI treatment

Exclusion Criteria

• Age < 18 years
• BMI > 35 kg/m2
• Oocyte donation
• HIV/ hepatitis
• Undiagnosed vaginal bleeding
• Uterine malformations
• Persisting ovarian cysts
• Tumors in Hypothalamus, pituitary, thyroid or adrenal
• Previous breast cancer
• BRCA1/2
• Unregulated thyroid disease
• Cardiovascular disease
• Breast feeding
• Present or previous chemotherapy/radiation therapy
• Present or previous malignant disease
• Smoking
• Alcohol/drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural cycle	Chorionic Gonadotropin, Alpha	These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer
Estradiol and progesterone	Estradiol Tablets	These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6
Gonadotropin	Chorionic Gonadotropin, Alpha	These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.
Estradiol and progesterone	Progesterone	These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6
Gonadotropin	Follitropin Alfa	These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.

Primary Outcome Measures

Name	Time	Method
Serum estradiol	10 weeks	Blood samples in the first 10 weeks of pregnancy
Serum progesterone	10 weeks	Blood samples in the first 10 weeks of pregnancy

Secondary Outcome Measures

Name	Time	Method
Child birth weight	At delivery	Weight of the child at delivery
Obstetric complications	9 months	Obsteric complication throughout pregnancy
Child malformations	9 months	Child malformations diagnosed in utero or at delivery
Gestational age at delivery	At delivery	Weeks of pregnancy when the child has been delivered

Trial Locations

Locations (1)

Herlev University Hospital; 🇩🇰 Herlev, Denmark