Estradiol and Progesterone Levels Following Frozen Embryo Transfer

NCT ID: NCT04997525

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2024-12-06

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Natural cycle

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

Group Type ACTIVE_COMPARATOR

Chorionic Gonadotropin, Alpha

Intervention Type DRUG

In either natural cycle or combined with Follitropin Alfa

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

Group Type ACTIVE_COMPARATOR

Estradiol Tablets

Intervention Type DRUG

Combined with progesterone

Progesterone

Intervention Type DRUG

Combined with estradiol

Gonadotropin

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

Group Type ACTIVE_COMPARATOR

Follitropin Alfa

Intervention Type DRUG

Combined with hCG

Chorionic Gonadotropin, Alpha

Intervention Type DRUG

In either natural cycle or combined with Follitropin Alfa

Interventions

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Estradiol Tablets

Combined with progesterone

Intervention Type DRUG

Progesterone

Combined with estradiol

Intervention Type DRUG

Follitropin Alfa

Combined with hCG

Intervention Type DRUG

Chorionic Gonadotropin, Alpha

In either natural cycle or combined with Follitropin Alfa

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Pernille Fog Svendsen, DMSc

DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Herlev University Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2020-001218-39

Identifier Type: -

Identifier Source: org_study_id

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