Estradiol and Progesterone Levels Following Frozen Embryo Transfer (ESTRO-FET)

Copenhagen University Hospital at Herlev

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Follitropin Alfa; Drug: Estradiol Tablets; Drug: Chorionic Gonadotropin, Alpha; Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT04997525

2020-001218-39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 305 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

305 participants in 3 patient groups

Natural cycle

Active Comparator group

Description:

These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer

Treatment:

Drug: Chorionic Gonadotropin, Alpha

Estradiol and progesterone

Active Comparator group

Description:

These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6

Treatment:

Drug: Progesterone

Drug: Estradiol Tablets

Gonadotropin

Active Comparator group

Description:

These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.

Treatment:

Drug: Chorionic Gonadotropin, Alpha

Drug: Follitropin Alfa