Estradiol levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer (FET) cycle

Phase 1

• Conditions: Infertile women; MedDRA version: 21.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-001218-39-DK
• Lead Sponsor: fertility clinic, Herlev university hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-21
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 300

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age < 18 years
•BMI > 35 kg/m2
•Day 6 blastocysts
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified