Estradiol and Progesterone Levels Following Frozen Embryo Transfer

Infertility Clinical Trial

— ESTRO-FET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04997525
• Other study ID #: 2020-001218-39
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 20, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Estradiol Tablets
Combined with progesterone
• Progesterone
Combined with estradiol
• Follitropin Alfa
Combined with hCG
• Chorionic Gonadotropin, Alpha
In either natural cycle or combined with Follitropin Alfa

Locations

Country	Name	City	State
Denmark	Herlev University Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum estradiol	Blood samples in the first 10 weeks of pregnancy	10 weeks
Primary	Serum progesterone	Blood samples in the first 10 weeks of pregnancy	10 weeks
Secondary	Gestational age at delivery	Weeks of pregnancy when the child has been delivered	At delivery
Secondary	Child birth weight	Weight of the child at delivery	At delivery
Secondary	Obstetric complications	Obsteric complication throughout pregnancy	9 months
Secondary	Child malformations	Child malformations diagnosed in utero or at delivery	9 months