Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle
Overview
- Phase
- Phase 4
- Intervention
- Chorionic Gonadotropin, Alpha
- Conditions
- Infertility
- Sponsor
- Copenhagen University Hospital at Herlev
- Enrollment
- 305
- Locations
- 1
- Primary Endpoint
- Serum estradiol
- Status
- Completed
- Last Updated
- last year
Overview
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 transfer (FET) cycles.
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 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.
Investigators
Pernille Fog Svendsen, DMSc
DMSc
Copenhagen University Hospital at Herlev
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
- •Unregulated thyroid disease
Arms & Interventions
Natural cycle
These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer
Intervention: Chorionic Gonadotropin, Alpha
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
Intervention: Estradiol Tablets
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
Intervention: Progesterone
Gonadotropin
These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.
Intervention: Follitropin Alfa
Gonadotropin
These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.
Intervention: Chorionic Gonadotropin, Alpha
Outcomes
Primary Outcomes
Serum estradiol
Time Frame: 10 weeks
Blood samples in the first 10 weeks of pregnancy
Serum progesterone
Time Frame: 10 weeks
Blood samples in the first 10 weeks of pregnancy
Secondary Outcomes
- Child malformations(9 months)
- Obstetric complications(9 months)
- Child birth weight(At delivery)
- Gestational age at delivery(At delivery)