NCT04356105

Brief Summary

Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

2 active sites

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

April 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

April 18, 2020

Last Update Submit

November 15, 2021

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    the number of oocytes collected from each participants in the two groups on the day of ovum pickup

    10 to 14 days

Secondary Outcomes (9)

  • Number of MII oocytes retrieved

    10 to 14 days

  • Number of fertilized oocytes

    2 days

  • Number of embryos transferred

    Day 3 after ovum pickup

  • Number of embryos cryopreserved

    Day 3 after ovum pickup

  • Chemical pregnancy rate

    14 days after embryo ransfer

  • +4 more secondary outcomes

Other Outcomes (2)

  • Cancellation rate

    10 to 14 days

  • Total dose of recombinant FSH

    10 to 14 days

Study Arms (2)

Minimal Stimulation Group

ACTIVE COMPARATOR

Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist

Drug: Minimal stimulation protocolProcedure: IVF/ICSI cycle

Microflare Group

ACTIVE COMPARATOR

Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH

Drug: Microflare protocolProcedure: IVF/ICSI cycle

Interventions

Minimal stimulation protocolDRUG

Letrozole, Recombinant FSH, GnRH antagonist

Also known as: Ovarian induction protocol
Minimal Stimulation Group
Microflare protocolDRUG

OCP, GnRH agonist, Recombinant FSH

Also known as: Ovarian induction protocol
Microflare Group
IVF/ICSI cyclePROCEDURE

Involving ovum pickup and embryo transfer

Microflare GroupMinimal Stimulation Group

Eligibility Criteria

Age30 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:
  • Advanced maternal age
  • Previous poor ovarian response
  • Abnormal tests of ovarian reserve (AFC \< 5-7, AMH \<0.5-1.1 ng/ml)

You may not qualify if:

  • Age \> 43 years
  • baseline FSH \>15 mIU/ml
  • Previous ovarian surgery
  • Ovarian endometrioma
  • Uterine anomaly or myoma
  • Any medical disorder
  • Any hormonal disorder eg. hyperprolactinemia
  • BMI \> 30 kg/m2
  • Severe male factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Cairo, 12311, Egypt

Location

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Sarwat Ahwany, MD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

April 18, 2020

First Posted

April 22, 2020

Study Start

June 1, 2020

Primary Completion

September 30, 2021

Study Completion

October 31, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations

EG(2)