NCT04278508

Brief Summary

To determine if different serum Progesterone levels on FET day are associated with different clinical pregnancy rates (CPR), and if increasing dosage of vaginal Progesterone in cases of lower serum Progesterone level on FET day can be either beneficial or detrimental regarding the CPR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

February 18, 2020

Last Update Submit

June 22, 2022

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Clinical pregnancy rate according to the presence of pregnancy sac on week 6-7 US.

    1 Year per patient

Secondary Outcomes (1)

  • Laboratory end other long term outcomes

    1 Year per patient

Study Arms (3)

Group A

ACTIVE COMPARATOR

P \< 10.0 ng/ml with increasing P dosage from 800 mg to 1200 mg daily from the FET day.

Drug: Progesterone

Group B

ACTIVE COMPARATOR

P \< 10.0 ng/ml without change in drug regimen.

Drug: Progesterone

Group C

ACTIVE COMPARATOR

P ≥ 10.0 ng/ml without change in drug regimen.

Drug: Progesterone

Interventions

ProgesteroneDRUG

To determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR)

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women between age 18-38 undergoing FET in AC
  • with body mass index (BMI) \< 35 kg/m2
  • a triple layer endometrium \>6.5 mm after exogenous estrogen administration
  • good quality day 3 or 5 FET.

You may not qualify if:

  • women with recurrent pregnancy losses (e.g. 2 abortions beyond 12th week or 3 abortions before 12th week)
  • recurrent implantation failure (e.g. unsuccessful implantation of ≥4 good quality embryos)
  • severe male factor (sperm concentration \<5 million/ml), or presence of hydrosalpinx.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 381000, Israel

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Einat Shalom-Paz, Prof.

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

March 9, 2020

Primary Completion

June 6, 2022

Study Completion

June 6, 2022

Last Updated

June 23, 2022

Record last verified: 2022-06

Locations

IL(1)