NCT04997525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

June 22, 2021

Last Update Submit

January 2, 2025

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

  • Serum estradiol

    Blood samples in the first 10 weeks of pregnancy

    10 weeks

  • Serum progesterone

    Blood samples in the first 10 weeks of pregnancy

    10 weeks

Secondary Outcomes (4)

  • Gestational age at delivery

    At delivery

  • Child birth weight

    At delivery

  • Obstetric complications

    9 months

  • Child malformations

    9 months

Study Arms (3)

Natural cycle

ACTIVE COMPARATOR

These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer

Drug: Chorionic Gonadotropin, Alpha

Estradiol and progesterone

ACTIVE COMPARATOR

These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6

Drug: Estradiol TabletsDrug: Progesterone

Gonadotropin

ACTIVE COMPARATOR

These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection.

Drug: Follitropin AlfaDrug: Chorionic Gonadotropin, Alpha

Interventions

Estradiol TabletsDRUG

Combined with progesterone

Estradiol and progesterone
ProgesteroneDRUG

Combined with estradiol

Estradiol and progesterone
Follitropin AlfaDRUG

Combined with hCG

Gonadotropin
Chorionic Gonadotropin, AlphaDRUG

In either natural cycle or combined with Follitropin Alfa

GonadotropinNatural cycle

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev University Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Infertility

Interventions

EstradiolProgesteronefollitropin alfaGlycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone CongenersChorionic GonadotropinGonadotropinsPeptide HormonesFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropinPlacental HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMSc

Study Record Dates

First Submitted

June 22, 2021

First Posted

August 9, 2021

Study Start

April 20, 2021

Primary Completion

May 7, 2024

Study Completion

December 6, 2024

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)