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

Primary Purpose

Infertility

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Estradiol Tablets
Progesterone
Follitropin Alfa
Chorionic Gonadotropin, Alpha
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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) after either IVF or ICSI treatment

Exclusion Criteria:

  • Age < 18 years
  • BMI > 35 kg/m2
  • Day 6 blastocysts
  • 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

Sites / Locations

  • Herlev University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Natural cycle

Estradiol and progesterone

Gonadotropin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum estradiol
Blood samples in the first 10 weeks of pregnancy
Serum progesterone
Blood samples in the first 10 weeks of pregnancy

Secondary Outcome Measures

Gestational age at delivery
Weeks of pregnancy when the child has been delivered
Child birth weight
Weight of the child at delivery
Obstetric complications
Obsteric complication throughout pregnancy
Child malformations
Child malformations diagnosed in utero or at delivery

Full Information

First Posted
June 22, 2021
Last Updated
February 20, 2023
Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Copenhagen University Hospital, Hvidovre
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1. Study Identification

Unique Protocol Identification Number
NCT04997525
Brief Title
Estradiol and Progestrone Levels Following Frozen Embryo Transfer
Acronym
ESTRO-FET
Official Title
Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Copenhagen University Hospital, Hvidovre

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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 tranfer (FET) cykles.
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 perfomed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Natural cycle
Arm Type
Active Comparator
Arm Description
These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer
Arm Title
Estradiol and progesterone
Arm Type
Active Comparator
Arm Description
These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6
Arm Title
Gonadotropin
Arm Type
Active Comparator
Arm Description
These women will receive daily gonadotropin injection before embryo tranfer. Ovulation will be stimulated using hCG injection.
Intervention Type
Drug
Intervention Name(s)
Estradiol Tablets
Intervention Description
Combined with progesterone
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
Combined with estradiol
Intervention Type
Drug
Intervention Name(s)
Follitropin Alfa
Intervention Description
Combined with hCG
Intervention Type
Drug
Intervention Name(s)
Chorionic Gonadotropin, Alpha
Intervention Description
In etiher natural cycle or combined with Follitropin Alfa
Primary Outcome Measure Information:
Title
Serum estradiol
Description
Blood samples in the first 10 weeks of pregnancy
Time Frame
10 weeks
Title
Serum progesterone
Description
Blood samples in the first 10 weeks of pregnancy
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Gestational age at delivery
Description
Weeks of pregnancy when the child has been delivered
Time Frame
At delivery
Title
Child birth weight
Description
Weight of the child at delivery
Time Frame
At delivery
Title
Obstetric complications
Description
Obsteric complication throughout pregnancy
Time Frame
9 months
Title
Child malformations
Description
Child malformations diagnosed in utero or at delivery
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pernille Fog Svendsen, DMSc
Phone
+4538689652
Email
pernille.fog.svendsen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Freiesleben Mørch, MD
Phone
+4522211671
Email
nina.freiesleben.moerch@regionh.dk
Facility Information:
Facility Name
Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pernille Fog Svendsen, DMSc
Phone
+4538689652
Email
pernille.fog.svendsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Nina Freiesleben Mørch, MD
Phone
+4522211671
Email
nina.freiesleben.moerch@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Estradiol and Progestrone Levels Following Frozen Embryo Transfer

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