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

Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Estradiol Tablets; Drug: Progesterone; Drug: Follitropin Alfa; Drug: Chorionic Gonadotropin, Alpha

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 Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Natural cycle; These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer	Drug: Chorionic Gonadotropin, Alpha; In either natural cycle or combined with Follitropin Alfa
Active Comparator: Estradiol and progesterone; These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6	Drug: Estradiol Tablets; Combined with progesterone; Drug: Progesterone; Combined with estradiol
Active Comparator: Gonadotropin; These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.	Drug: Follitropin Alfa; Combined with hCG; Drug: Chorionic Gonadotropin, Alpha; In either natural cycle or combined with Follitropin Alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum estradiol	Blood samples in the first 10 weeks of pregnancy	10 weeks
Serum progesterone	Blood samples in the first 10 weeks of pregnancy	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev
• Collaborators: Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): May 7, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Estrogens; Progestins; Estradiol; Follicle Stimulating Hormone; Progesterone; Chorionic Gonadotropin
• Other Study ID Numbers: 2020-001218-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No