Clinical trial

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

Name
2020-001218-39
Description
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.
Trial arms
Trial start
2021-04-20
Estimated PCD
2024-05-07
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Estradiol Tablets
Combined with progesterone
Arms:
Estradiol and progesterone
Progesterone
Combined with estradiol
Arms:
Estradiol and progesterone
Follitropin Alfa
Combined with hCG
Arms:
Gonadotropin
Chorionic Gonadotropin, Alpha
In either natural cycle or combined with Follitropin Alfa
Arms:
Gonadotropin, Natural cycle
Size
300
Primary endpoint
Serum estradiol
10 weeks
Serum progesterone
10 weeks
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 * BRCA1/2 * Unregulated thyroid disease * Cardiovascular disease * Breast feeding * Present or previous chemotherapy/radiation therapy * Present or previous malignant disease * Smoking * Alcohol/drug abuse
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-05-14

1 organization

4 products

1 indication

Product
Estradiol
Indication
infertility