ESTRO-FET: Estradiol and Progestrone Levels Following Frozen Embryo Transfer

• Sponsor: Copenhagen University Hospital at Herlev (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04997525
• Collaborator: Copenhagen University Hospital, Hvidovre (Other)
• Enrollment: 300
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 31.4
• Patients Per Site: 150
• Patients Per Site Per Month: 4.8

Study Details

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.

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 either ovulatory or anovulatory when referred to fertility treatment. Ovulatory women will be randomized to either natural cykle or estradiol + progesterone cykle treatment for FET. Anovulatory women will be randomized to either estradiol + progesterone cykle or gonadotropin cykle treatment for FET.

Included women will undergo weekly blood testing for serum estradiol and progesterone levels until gestational age 9+6. They will also have routine vaginal ultrasound as well as additional pregnancy ultrasounds performed.

Secondary obstetric outcomes will be investigated using the womens medical journals.

All the treatments are standard treatments in Denmark for FET.

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 20, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Serum estradiol [10 weeks]

   Blood samples in the first 10 weeks of pregnancy

2. Serum progesterone [10 weeks]

   Blood samples in the first 10 weeks of pregnancy

Secondary Outcome Measures

1. Gestational age at delivery [At delivery]

   Weeks of pregnancy when the child has been delivered

2. Child birth weight [At delivery]

   Weight of the child at delivery

3. Obstetric complications [9 months]

   Obsteric complication throughout pregnancy

4. Child malformations [9 months]

   Child malformations diagnosed in utero or at delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herlev University Hospital	Herlev		Denmark	2730
2	Hvidovre University Hospital	Hvidovre		Denmark	2605

Sponsors and Collaborators

• Copenhagen University Hospital at Herlev
• Copenhagen University Hospital, Hvidovre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Aug 9, 2021
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Infertility; Chorionic Gonadotropin; Estradiol; Progesterone; Follicle Stimulating Hormone

Study Results

No Results Posted as of Aug 9, 2021