Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Delayed Start to Ovarian Stimulation

Short name DOS/DOR

NCTNCT01614067Other idUCSF 11-07259

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Slow enrollment resulted in withdraw of funding

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 30 participants (actual)
Sponsor: University of California, San Francisco · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: May 2012
Primary completion: Jul 2014
Completion: Sept 2014
First posted: 7 Jun 2012 (estimated)
Last update posted: 15 Jun 2021
Conditions: Diminished Ovarian Reserve · Infertility · In Vitro Fertilization

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015

Ph 4
DOS/DOR
NCT01614067
May 2012 to Sept 2014
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Ganirelix acetateDrug

Arms2

Experimental
Delayed Start
Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.
Active comparator
Conventional Start
Ovarian stimulation with standard antagonist protocols (no delay).

Primary outcomes2

Outcomes the sponsor listed as primary.

Fertilization Proportions
Time frame · 8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization
Registry description
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.
Number of Oocytes Retrieved
Time frame · up to 1 hour after oocytes retrieved
Registry description
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

Secondary outcomes(5)

Embryo Quality
Time frame · One hour on day 2 or 3 (following IVF procedure)
Registry description
Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells.
Pregnancy Rates
Time frame · 2 to 3 weeks following embryo transfer
Registry description
Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value \> 5 mIU/ml ) observed over the time frame.
Stages of Oocyte Nuclear Maturation
Time frame · average of 1 to 2 hours on the Day of Retrieval
Registry description
Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II)
Number of Mature Follicles
Time frame · up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes)
Registry description
Maturation of follicles will be assessed by measuring the size of follicles (mature \> 13mm) prior to (or at the time of) oocytes retrieval.
Oocyte Recovery Rate
Time frame · up to 1 hours after oocyte retrieval
Registry description
The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Fertilization Proportions

Group	Value
Delayed Start	not posted
Conventional Start	not posted

Primary outcome· up to 1 hour after oocytes retrieved

Number of Oocytes Retrieved

Group	Value
Delayed Start	not posted
Conventional Start	not posted

Secondary and other outcome results(5)

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

Embryo Quality

Group	Value
Delayed Start	not posted
Conventional Start	not posted

Secondary outcome· 2 to 3 weeks following embryo transfer

Pregnancy Rates

Group	Value
Delayed Start	not posted
Conventional Start	not posted

Secondary outcome· average of 1 to 2 hours on the Day of Retrieval

Stages of Oocyte Nuclear Maturation

Group	Value
Delayed Start	not posted
Conventional Start	not posted

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

Number of Mature Follicles

Group	Value
Delayed Start	not posted
Conventional Start	not posted

Secondary outcome· up to 1 hours after oocyte retrieval

Oocyte Recovery Rate

Group	Value
Delayed Start	not posted
Conventional Start	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Delayed StartStudy subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH. Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist	0 / 15	0 / 15	0 / 15
Conventional StartOvarian stimulation with standard antagonist protocols (no delay). Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist	0 / 15	0 / 15	0 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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). Exclusion Criteria: * 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).

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