A Phase 4 interventional study of hCG and hCG in Ovarian Hyperstimulation Syndrome, sponsored by UConn Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by UConn Health · Phase 4, Interventional, and Treatment
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.
Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. GnRH agonist trigger has been shown to be effective in OHSS prevention. However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.
Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has been shown that optimal conception rates is not achieved for high risk patients with peak serum E2 \< 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later will rescue some of the corpora lutea and help improve corpora lutea function and improve pregnancy rates.
The study will evaluate patients at high risk of OHSS development with peak serum E2 \< 4,000 pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy rates or risk of OHSS. Markers of corpus luteum function such as serum 17 hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus luteum function.
64 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.
This study's enrollment of 89 is below the median of 100 across 48 interventional studies indexed under Ovarian Hyperstimulation Syndrome.
Browse Ovarian Hyperstimulation Syndrome studies →UConn Health is the lead sponsor of 182 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger. Placebo administered 35 hours after GnRH agonist trigger
Drug: hCG
Placebo administered at the time of GnRH agonist trigger Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.
Drug: hCG
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger
Also known as: Pregnyl, Profasi
Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Also known as: Pregnyl, Profasi
Ongoing Pregnancy
Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .
Time frame: Through time of study completion, on average 1-2years
Ovarian Hyperstimulation Syndrome
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.
Time frame: Within 4 weeks of oocyte retrieval
Markers of Corpus Luteum Function
A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.
Time frame: Within 60 days after trigger of oocyte maturation
Proportion of Patients With Abdominal Distension
Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.
Time frame: Within 2 weeks after trigger of oocyte maturation
| Milestone | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger |
|---|---|---|
| Started | 34 | 37 |
| Completed | 26 | 31 |
| Not completed | 8 | 6 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Physician decision | 8 | 5 |
Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .
| participants | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger |
|---|---|---|
| Ongoing Pregnancy | 15 | 19 |
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.
| Participants | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger |
|---|---|---|
| Ovarian Hyperstimulation Syndrome | 1 | 3 |
A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.
| ng/mL | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger |
|---|---|---|
| Early luteal 17-OH-Progesterone | 13.68 ± 11.0 | 21.77 ± 8.5 |
| Day 16 Prorenin | 1.13 ± 0.8 | 2.22 ± 1.6 |
Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.
| Participants | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger |
|---|---|---|
| Abdominal distension | 2 | 11 |
| abdominal pain | 1 | 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| hCG Given at Time of GnRHa Trigger | 0/26 (0%) | 1/26 (3.8%) | 0/26 (0%) |
| hCG Given 35 Hours After GnRHa Trigger | 0/31 (0%) | 1/31 (3.2%) | 0/31 (0%) |
| Event | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger |
|---|---|---|
| Ectopic PregnancyPregnancy, puerperium and perinatal conditions | 1/26 | 1/31 |
| Age, Continuous(years) | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger | Total |
|---|---|---|---|
| Mean | 31.3 ± 3.3 | 32.2 ± 3.4 | 31.8 ± 3.4 |
| Sex: Female, Male(Participants) | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger | Total |
|---|---|---|---|
| Female | 26 | 31 | 57 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body Mass Index (BMI)("kg/m^2") | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger | Total |
|---|---|---|---|
| Mean | 26.3 ± 4.8 | 27.4 ± 5.5 | 26.9 ± 5.2 |
| Anti Mullerian Hormone (AMH)(ng/ml) | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger | Total |
|---|---|---|---|
| Mean | 8.3 ± 5.8 | 8.4 ± 4.9 | 8.35 ± 5.2 |
| Follicle Stimulating Hormone (FSH)(IU/L) | hCG Given at Time of GnRHa Trigger | hCG Given 35 Hours After GnRHa Trigger | Total |
|---|---|---|---|
| Mean | 5.6 ± 1.7 | 5.2 ± 1.6 | 5.5 ± 2.1 |
Plan to share: Undecided
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ovarian Hyperstimulation Syndrome→
UConn Health