NCT01614067

Brief Summary

In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

June 15, 2021

Completed
Last Updated

June 15, 2021

Status Verified

May 1, 2021

Enrollment Period

2.2 years

First QC Date

May 2, 2012

Results QC Date

May 20, 2021

Last Update Submit

May 20, 2021

Conditions

Diminished Ovarian ReserveInfertilityIn Vitro Fertilization

Keywords

DORInfertilityIVFARTGnRHaGnRH Antagonist ProtocolGanirelix

Outcome Measures

Primary Outcomes (2)

  • Fertilization Proportions

    Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval.

    8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization

  • Number of Oocytes Retrieved

    The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted

    up to 1 hour after oocytes retrieved

Secondary Outcomes (5)

  • Embryo Quality

    One hour on day 2 or 3 (following IVF procedure)

  • Pregnancy Rates

    2 to 3 weeks following embryo transfer

  • Stages of Oocyte Nuclear Maturation

    average of 1 to 2 hours on the Day of Retrieval

  • Number of Mature Follicles

    up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes)

  • Oocyte Recovery Rate

    up to 1 hours after oocyte retrieval

Study Arms (2)

Delayed Start

EXPERIMENTAL

Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.

Drug: Ganirelix acetate

Conventional Start

ACTIVE COMPARATOR

Ovarian stimulation with standard antagonist protocols (no delay).

Drug: Ganirelix acetate

Interventions

Ganirelix acetateDRUG

Subjects will receive 7 days of pre-treatment with the GnRH antagonist

Also known as: Ganirelix
Conventional StartDelayed Start

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal ultrasound (TVUS), or
  • Cancellation of a prior IVF cycle due to poor ovarian response.
  • Patients will receive an antagonist stimulation protocol for IVF, or IVF with Intracytoplasmic Sperm Injection (ICSI).

You may not qualify if:

  • Severe male factor infertility requiring surgical intervention to obtain sperm
  • Major uterine abnormality,
  • Preimplantation genetic diagnostic (PGD) testing,
  • Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate cycles).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Center for Reproductive Health

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Blockeel C, Riva A, De Vos M, Haentjens P, Devroey P. Administration of a gonadotropin-releasing hormone antagonist during the 3 days before the initiation of the in vitro fertilization/intracytoplasmic sperm injection treatment cycle: impact on ovarian stimulation. A pilot study. Fertil Steril. 2011 Apr;95(5):1714-9.e1-2. doi: 10.1016/j.fertnstert.2011.01.028.

    PMID: 21300334BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

ganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Mitchell Rosen, MD
Organization
University of California, San Francisco
415-353-7475

Study Officials

  • Mitchell Rosen, MD

    UCSF Center for Reproductive Health and Fertility Preservation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2012

First Posted

June 7, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

June 15, 2021

Results First Posted

June 15, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)