NCT04052607

Brief Summary

Stimulation protocols for IVF underwent several cycles of upgrading aiming to achieve reasonable outcomes with low-cost cycles. Antagonist protocols have been introduced as effective and comparable to long agonist regarding the outcomes. However, these protocols are still costly. Alternative protocols using progestin suppressions appear options for consideration.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

August 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

August 8, 2019

Last Update Submit

June 12, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Live Birth after first Vitrified-warmed cycle

    Delivery of one or more viable infants \> 20th weeks of gestation

    42 weeks of gestation

Secondary Outcomes (21)

  • Biochemical pregnancy

    14 days after egg retrieval

  • Clinical pregnancy

    within 12 weeks of gestation

  • Ongoing pregnancy

    within 24 weeks of pregnancy

  • Miscarriage

    Within 20 weeks of pregnancy

  • Term live-birth for vitrified-warmed transfer

    Within 42 weeks of gestation

  • +16 more secondary outcomes

Study Arms (3)

Dydrogesterone Suppression

EXPERIMENTAL

Dydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent luteinizing hormone (LH) surge. The stimulation is with 150-300 IU FSH/HMG starting on cycle day 2 and adjusted according to the AFC and AMH.

Drug: LH Suppression

Dydrogesterone Suppression with minimal stimulation

EXPERIMENTAL

Dydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent LH surge. The stimulation is with clomifene citrate 50 mg three times daily with150 IU FSH starting on cycle day 2 and continued every other day and adjusted according to the AFC and AMH.

Drug: LH Suppression

Antagonist Suppression

ACTIVE COMPARATOR

cetrorelix acetate 0.25 started on stimulation day 6 till the trigger day to prevent LH surge. The stimulation is with150-300 IU FSH starting on cycle day 2 and continued daily and adjusted according to the AFC and AMH.

Drug: LH Suppression

Interventions

LH SuppressionDRUG

Stimulation protocols

Antagonist SuppressionDydrogesterone SuppressionDydrogesterone Suppression with minimal stimulation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women age of ≥ 18 to ≤ 40;
  • BMI of ≤ 31;
  • All indication for freeze-all
  • PCOS;
  • Women who have ≥ 1 year of primary or secondary infertility;
  • Tubal factor (unilateral, bilateral obstruction or salpingectomy);
  • Fresh ejaculate sperm of any count provided they have ≥ 1% normal forms and a motile fraction;
  • Women undergoing their first ICSI cycle or following a previous successful attempt;
  • Women undergoing only frozen-thawed embryo transfer;
  • Women with \> 8 mm endometrial thickness at the day of progesterone supplementation in the transfer cycle;
  • Women with no detected uterine abnormality on transvaginal ultrasound (e.g. submucosal myomas, polyps or septa).

You may not qualify if:

  • Unilateral oophorectomy;
  • Uterine pathology or abnormality;
  • Abnormal karyotyping for them or their male partners;
  • History of repeated abortions or implantation failure;
  • Uncontrolled diabetes;
  • Liver or renal disease;
  • History of malignancy or borderline pathology;
  • Endometriosis;
  • Plan for PGD-A;
  • Severe male factor includes surgical sperm retrieval or cryopreserved sperm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Banon Fertility Center

Asyut, Egypt

Location

IbnSina IVF Center, IbnSina Hospital

Sohag, 12345, Egypt

Location

AlRahma Hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mohamed Fawzy

    Ibnsina Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 12, 2019

Study Start

September 10, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)