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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04997525
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : February 22, 2023
Sponsor:
Collaborator:
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Pernille Fog Svendsen, DMSc, Copenhagen University Hospital at Herlev

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Estradiol Tablets Drug: Progesterone Drug: Follitropin Alfa Drug: Chorionic Gonadotropin, Alpha Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 etiher 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 tranfer. Ovulation will be stimulated using hCG injection.
 Drug: Follitropin Alfa
Combined with hCG

Drug: Chorionic Gonadotropin, Alpha
In etiher natural cycle or combined with Follitropin Alfa


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997525


Contacts
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Contact: Pernille Fog Svendsen, DMSc +4538689652 pernille.fog.svendsen@regionh.dk
Contact: Nina Freiesleben Mørch, MD +4522211671 nina.freiesleben.moerch@regionh.dk

Locations
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Denmark
Herlev University Hospital Recruiting
Herlev, Denmark, 2730
Contact: Pernille Fog Svendsen, DMSc    +4538689652    pernille.fog.svendsen@regionh.dk   
Contact: Nina Freiesleben Mørch, MD    +4522211671    nina.freiesleben.moerch@regionh.dk   
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Copenhagen University Hospital, Hvidovre
More Information
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Responsible Party: Pernille Fog Svendsen, DMSc, DMSc, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT04997525    
Other Study ID Numbers: 2020-001218-39
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Infertility
Chorionic Gonadotropin
Estradiol
Progesterone
Follicle Stimulating Hormone
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Progestins