NCT04407052

Brief Summary

The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle triggered by HCG.

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
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 25, 2020

Last Update Submit

May 28, 2020

Conditions

Keywords

IVFHCGGnRH agonist trigger

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    First day after oocyte retrieval

Secondary Outcomes (1)

  • Clinical pregnancy rate

    First 5 weeks after oocyte retrieval

Study Arms (2)

Double trigger

EXPERIMENTAL

GnRH-agonist and HCG are used to trigger ovulation

Drug: Double trigger

HCG

ACTIVE COMPARATOR

HCG is used to trigger ovulation

Drug: HCG trigger

Interventions

Final follicular maturation is triggered by the coadministration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively

Double trigger

Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval

HCG

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with history of low proportion of mature oocytes in previous IVF attempt (triggered by HCG).
  • Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

You may not qualify if:

  • Endometriosis
  • PCOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Fertility and Reproductive Health center

Giza, Egypt

RECRUITING

Related Publications (1)

  • Zilberberg E, Haas J, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG, for final oocyte maturation (double trigger), in patients with low proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.

    PMID: 25385007BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Officials

  • Usama M Fouda, Prof.

    Riyadh Fertility and Reproductive Health center

    STUDY CHAIR

Central Study Contacts

Usama M Fouda, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 29, 2020

Study Start

May 30, 2020

Primary Completion

December 31, 2020

Study Completion

February 2, 2021

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations