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
Organization
Copenhagen University Hospital at HerlevProduct
EstradiolIndication
infertilityProduct
ProgesteroneProduct
Follitropin AlfaProduct
Chorionic Gonadotropin