Estradiol and Progestrone Levels Following Frozen Embryo Transfer

Study Overview
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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 tranfer (FET) cykles.

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 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.

Official Title
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Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle

Conditions
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Infertility

Intervention / Treatment
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* Drug: Estradiol Tablets
* Drug: Progesterone
* Drug: Follitropin Alfa
* Drug: Chorionic Gonadotropin, Alpha


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Natural cycle<br>These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer | Drug: Chorionic Gonadotropin, Alpha<br>* In etiher natural cycle or combined with Follitropin Alfa<br>|
| Active Comparator: Estradiol and progesterone<br>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<br>* Combined with progesterone<br>Drug: Progesterone<br>* Combined with estradiol<br>|
| Active Comparator: Gonadotropin<br>These women will receive daily gonadotropin injection before embryo tranfer. Ovulation will be stimulated using hCG injection. | Drug: Follitropin Alfa<br>* Combined with hCG<br>Drug: Chorionic Gonadotropin, Alpha<br>* In etiher natural cycle or combined with Follitropin Alfa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum estradiol | Blood samples in the first 10 weeks of pregnancy | 10 weeks | 
| Serum progesterone | Blood samples in the first 10 weeks of pregnancy | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery | Weeks of pregnancy when the child has been delivered | At delivery | 
| Child birth weight | Weight of the child at delivery | At delivery | 
| Obstetric complications | Obsteric complication throughout pregnancy | 9 months | 
| Child malformations | Child malformations diagnosed in utero or at delivery | 9 months |