Infertility
Conditions
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.
Interventions
Combined with progesterone
DRUGProgesterone
Combined with estradiol
DRUGFollitropin Alfa
Combined with hCG
DRUGChorionic Gonadotropin, Alpha
In either natural cycle or combined with Follitropin Alfa
Sponsors
Copenhagen University Hospital, Hvidovre
Copenhagen University Hospital at Herlev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum estradiol | 10 weeks | Blood samples in the first 10 weeks of pregnancy |
| Serum progesterone | 10 weeks | Blood samples in the first 10 weeks of pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at delivery | At delivery | Weeks of pregnancy when the child has been delivered |
| Child birth weight | At delivery | Weight of the child at delivery |
| Obstetric complications | 9 months | Obsteric complication throughout pregnancy |
| Child malformations | 9 months | Child malformations diagnosed in utero or at delivery |
Countries
Denmark
Outcome results
None listed