Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Study of Dual Trigger Ovulation in Oocyte Donors

Short name DUALTRIGGER

NCTNCT01443546Other id1011011394

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Unable to complete accrual

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 26 participants (actual)
Sponsor: Weill Medical College of Cornell University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jan 2013
Primary completion: Jun 2016
Completion: Jun 2016
First posted: 29 Sept 2011 (estimated)
Last update posted: 26 Jun 2019
Conditions: Infertility

Timeline

1 trial · 1 stopped early · 1 with posted results

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

20132014201520162017

Ph 4
DUALTRIGGER
NCT01443546
Jan 2013 to Jun 2016
Terminated
Terminated

Registry summary

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

The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.

Interventions

HCGDrug
Lupron TriggerDrug
Dual TriggerDrug

Arms3

Active comparator
hCG
standard dose of hCG for ovulation trigger
Active comparator
Lupron Trigger
Leuprolide acetate 2 mg ovulation trigger
Experimental
Dual Trigger
Lupron and hCG combined ovulation trigger

Primary outcomes3

Outcomes the sponsor listed as primary.

Number of Subjects Having Adverse Events
Time frame · 1 month
Registry description
Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded
Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities
Time frame · 7 days post retrieval
Registry description
Subjects will complete a brief questionnaire on post retrieval day 7. They will state how many days after retrieval they were able to resume their usual activities.
Ovarian Volume
Time frame · 7 days post retrieval
Registry description
Ovarian volume of both ovaries will be measured by ultrasound on post op day number 7. Measurements will be taken in three different dimensions and volume calculated from those measurements.

Secondary outcomes(2)

Number of Mature Oocytes Retrieved
Time frame · 1 day post ovulation
Registry description
Number of mature oocytes retrieved will assess the efficacy of the intervention
Pregnancies Per Transfer
Time frame · 4 weeks post retrieval
Registry description
Pregnancy rate per transfer will be assessed by hCG level on day 14 post retrieval and clinical pregnancy rate will be assessed by ultrasound on day 28 post retrieval. This will additionally assess efficacy of intervention.

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 outcomeNumber· 1 month

Number of Subjects Having Adverse Events

Group	Value (participants)
hCG Trigger	0
Dual Trigger	1
Lupron Trigger	0

Primary outcome· 7 days post retrieval

Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities

Group	Value
hCG Trigger	not posted
Dual Trigger	not posted
Lupron Trigger	not posted

Primary outcome· 7 days post retrieval

Ovarian Volume

Group	Value
hCG Trigger	not posted
Lupron Trigger	not posted
Dual Trigger	not posted

Secondary and other outcome results(2)

Secondary outcome· 1 day post ovulation

Number of Mature Oocytes Retrieved

Group	Value
hCG Trigger	not posted
Dual Trigger	not posted
Lupron Trigger	not posted

Secondary outcome· 4 weeks post retrieval

Pregnancies Per Transfer

Group	Value
hCG Trigger	not posted
Lupron Trigger	not posted
Dual Trigger	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
hCG Triggerstandard dose of hCG for ovulation trigger HCG: hCG Trigger	0 / 9	0 / 9	0 / 9
Dual TriggerLupron and hCG combined ovulation trigger Dual Trigger: a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).	0 / 8	1 / 8	0 / 8
Lupron TriggerLeuprolide acetate 2 mg ovulation trigger Lupron Trigger: leuprolide acetate 2 mg SQ	0 / 9	0 / 9	1 / 9

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 21 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: Donors * Young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements for donation. Recipients * Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements to be recipients of donated eggs. Exclusion Criteria: Donors * Less than 2 ovaries or any other significant ovarian abnormality * Does not meet current FDA or program requirements for donation. * A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts) * A contraindication for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding) * Known gene defects, genetic abnormalities or abnormal karyotype * Contraindication or hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol * Inability to give informed consent * Donors who, because of their place of residence or personal situation, would not be able to commit to all required time points including the one extra visit required by study participation. * The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease

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