Skip to main content
OpenTrials
Completed

NCT Number: NCT04997525

Estradiol and Progesterone Levels Following Frozen Embryo Transfer

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Herlev University Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol Tablets

Drug

Combined with progesterone

Progesterone

Drug

Combined with estradiol

Follitropin alfa

Drug

Combined with hCG

Chorionic Gonadotropin, Alpha

Drug

In either natural cycle or combined with Follitropin Alfa

Primary outcomes

  1. Serum estradiol

    Time frame: 10 weeks

    Blood samples in the first 10 weeks of pregnancy

  2. Serum progesterone

    Time frame: 10 weeks

    Blood samples in the first 10 weeks of pregnancy

Secondary outcomes

  1. Gestational age at delivery

    Time frame: At delivery

    Weeks of pregnancy when the child has been delivered

  2. Child birth weight

    Time frame: At delivery

    Weight of the child at delivery

  3. Obstetric complications

    Time frame: 9 months

    Obsteric complication throughout pregnancy

  4. Child malformations

    Time frame: 9 months

    Child malformations diagnosed in utero or at delivery

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Collaborators

  • Copenhagen University Hospital, Hvidovre

Registry information

Official study title

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

Acronym: ESTRO-FET

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2021
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.