Primary outcomeNumber· Through time of study completion, on average 1-2years
Ongoing Pregnancy
| Group | Value (participants) |
|---|---|
| hCG Given at Time of GnRHa Trigger | 15 |
| hCG Given 35 Hours After GnRHa Trigger | 19 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataCo-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS
NCTNCT01815138 (opens ClinicalTrials.gov in a new tab)Other id13-098-3
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 89 participants (actual)
- Sponsor
- UConn Health · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Mar 2013
- Primary completion
- Dec 2015
- Completion
- Oct 2016
- First posted
- 20 Mar 2013 (estimated)
- Last update posted
- 26 Oct 2018
- Conditions
- Ovarian Hyperstimulation Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20132014201520162017
- Ph 4
Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS
NCT01815138Mar 2013 to Oct 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This a prospective randomized double blind study involving patients at high risk of OHSS development with peak serum E2 levels \< 4,000 pg/ml comparing the ongoing pregnancy rates in patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant hCG 1,500 IU 35 hours after GnRH agonist trigger.
Interventions
- hCGDrug
- hCGDrug
Arms2
Experimental
hCG given at time of GnRHa trigger
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger. Placebo administered 35 hours after GnRH agonist trigger
Active comparator
hCG given 35 hours after GnRHa trigger
Placebo administered at the time of GnRH agonist trigger Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.
Primary outcomes1
Outcomes the sponsor listed as primary.
Ongoing Pregnancy
Time frame · Through time of study completion, on average 1-2years
Registry description
Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .
Secondary outcomes(1)
Ovarian Hyperstimulation Syndrome
Time frame · Within 4 weeks of oocyte retrieval
Registry description
Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeCount of participants· Within 4 weeks of oocyte retrieval
Ovarian Hyperstimulation Syndrome
| Group | Value (Participants) |
|---|---|
| hCG Given at Time of GnRHa Trigger | 1 |
| hCG Given 35 Hours After GnRHa Trigger | 3 |
Other pre specified outcomeMean· Within 60 days after trigger of oocyte maturation
Markers of Corpus Luteum Function
| Group | Value (ng/mL) | Spread |
|---|---|---|
| hCG Given at Time of GnRHa Trigger | 13.68 | 11.0 |
| hCG Given 35 Hours After GnRHa Trigger | 21.77 | 8.5 |
Other pre specified outcomeCount of participants· Within 2 weeks after trigger of oocyte maturation
Proportion of Patients With Abdominal Distension
| Group | Value (Participants) |
|---|---|
| hCG Given at Time of GnRHa Trigger | 2 |
| hCG Given 35 Hours After GnRHa Trigger | 11 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| hCG Given at Time of GnRHa TriggerAdjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger. Placebo administered 35 hours after GnRH agonist trigger hCG: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger | 0 / 26 | 1 / 26 | 0 / 26 |
| hCG Given 35 Hours After GnRHa TriggerPlacebo administered at the time of GnRH agonist trigger Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger. hCG: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger | 0 / 31 | 1 / 31 | 0 / 31 |
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.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedKaye L, Griffin D, Thorne J, Neuber E, Nulsen J, Benadiva C, Engmann L. Independent serum markers of corpora lutea function after gonadotropin-releasing hormone agonist trigger and adjuvant low dose human chorionic gonadotropin in in vitro fertilization. Fertil Steril. 2019 Sep;112(3):534-544. doi: 10.1016/j.fertnstert.2019.04.034. Epub 2019 Jun 18. PMID 31227286
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 39 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have \> 14 follicles of over 11 mm in diameter and with peak serum E2 levels \< 4,000 pg/mL on the day of trigger of oocyte maturation.
Exclusion Criteria:
* Hypothalamic dysfunction, Patients with \< 14 follicles \< 11 mm in diameter, peak serum E2 levels \>= 4,000 pg/mL.
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