NCT03938064

Brief Summary

It is already known that all stimulated IVF ICSI cycles needs luteal phase support for higher pregnancy rates The current study will focus on evaluating two different starting times of luteal phase support

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2019

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

May 2, 2019

Last Update Submit

July 30, 2019

Conditions

Infertility

Keywords

poor respondersIVF/ICSILuteal Phase SupportGnRH Antagonist Protocol

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rates

    number of pregnancies completing 20 weeks or more gestational age expressed per patient

    20 weeks

Secondary Outcomes (2)

  • clinical pregnancy rate

    8 weeks

  • miscarriage rate

    24 weeks

Study Arms (2)

Group Early start

ACTIVE COMPARATOR

group will include 260 women with POR undergoing a trial of IVF/ICSI. This group will receive vaginal micronized progesterone pessaries from the day of ovum retrieval (OR).

Drug: Prontogest 400 mg vaginal pessaries

Group Late start

PLACEBO COMPARATOR

group will include 260 women with POR undergoing a trial of IVF/ICSI. This group will receive vaginal micronized progesterone pessaries 2 days after OR.

Drug: Prontogest 400 mg vaginal pessaries

Interventions

Prontogest 400 mg vaginal pessariesDRUG

natural progesterone in the form of vaginal suppositories 400 mg

Also known as: placebo vaginal pessaries
Group Early startGroup Late start

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- At least two of the following three features must be present Advanced maternal age (40 years) or any other risk factor for Poor Ovarian Response
  • A previous POR (≤3 oocytes with a conventional stimulation protocol):
  • An abnormal ovarian reserve test (ORT): (i.e. AFC\< 5-7 follicles or AMH 0.5-1.1ng/ml Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT By definition, the term POR refers to the ovarian response and, therefore, one stimulation cycle is considered essential for the diagnosis of POR, However, patients over 40 years of age with abnormal ORT may be classified as poor responders since both advanced age and an abnormal ORT may indicate reduced ovarian reserve and act as surrogate of ovarian stimulation cycle. in this case, the patients should be more properly defined as expected PORs

You may not qualify if:

  • \- Severe husband semen oligo terato atheno spermia
  • Abnormal karyotyping of one or both couples
  • Congenital and acquired uterine abnormalities
  • Antiphospholipid Antibody syndrome
  • Untreated hydrosalpinx
  • Women intending to do PGD or screening
  • Thin endometrium (\< 7 mm) at day of HCG
  • Premature luteinization (P\> 2 ng/ml or P/E2 ratio \> 1 on the day of HCG)
  • Ovarian follicle \> 10 mm and/or E2 \> 40 pg/ml at day2 of stimulation cycle
  • Less than two follicles (≥ 17mm) and/or E2 \< 500 pg/ml at day of HCG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ART unit - Ain Shams university Matrnity Hospital

Cairo, Egypt

RECRUITING

Private fertility care centers

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

mostafa f gomaa, Investigator

CONTACT

00201226188993mostafafouadg@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

June 26, 2019

Primary Completion

January 1, 2021

Study Completion

July 1, 2021

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations

EG(2)