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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001218-39-DK

Enrollment

400

Registered

2020-04-21

Start date

2020-11-17

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile women MedDRA version: 27.1 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Estradiol Product Name: estradiol Product Code: G03CA03 Pharmaceutical Form: Tablet INN or Proposed INN: estradiol CAS Number: 50-28-2 Current Sponsor code: estradiol Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age > 18 years =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Age 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
Main Objective: To investigate plasma estradiol and progesterone levels in early pregnancy in women who have conceived after transfer of thawed blastocysts in an either natural or hormonstimulated cycle.;Secondary Objective: To investigate Obstetrical outcomes after FET cycles, blood markers of thyroid function, metabolism and markers of pre eclampsia;Primary end point(s): Plasma estradiol and progesterone koncentration in early pregnancy;Timepoint(s) of evaluation of this end point: Measurements wil be performed every second week in the first 10 weeks of pregnancy	—

Measure

Time frame

Main Objective: To investigate plasma estradiol and progesterone levels in early pregnancy in women who have conceived after transfer of thawed blastocysts in an either natural or hormonstimulated cycle.;Secondary Objective: To investigate Obstetrical outcomes after FET cycles, blood markers of thyroid function, metabolism and markers of pre eclampsia;Primary end point(s): Plasma estradiol and progesterone koncentration in early pregnancy;Timepoint(s) of evaluation of this end point: Measurements wil be performed every second week in the first 10 weeks of pregnancy

—

Secondary

Measure	Time frame
Secondary end point(s): Pregnancy rates and outcome. Markers of thyroid function, metabolism and pre eclampsia;Timepoint(s) of evaluation of this end point: Obstetrical outcomes evaluated after delivery Markers of thyroid function metabolism and pre eclampsia wil be evaluated durin stmimulation cycle and every second week in the first 10 weeks of pregnancy	—

Countries

Denmark

Contacts

Public ContactFertility clinic Herlev University

Fertility clinic Herlev University Hospital

pernille.fog.svendsen@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026