Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

NCT01815138 | Completed Phase 4 Results DMC

• 1 other identifier: 13-098-3
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSS, GnRH agonist trigger, low dose hCG, PCOS, IVF

Outcome Measures

Primary Outcomes (1)

• Ongoing Pregnancy

  Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .

  Through time of study completion, on average 1-2years

Secondary Outcomes (1)

• Ovarian Hyperstimulation Syndrome

  Within 4 weeks of oocyte retrieval

Other Outcomes (2)

• Markers of Corpus Luteum Function

  Within 60 days after trigger of oocyte maturation

• Proportion of Patients With Abdominal Distension

  Within 2 weeks after trigger of oocyte maturation

Study Arms (2)

hCG given at time of GnRHa trigger

EXPERIMENTAL

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

hCG given 35 hours after GnRHa trigger

ACTIVE COMPARATOR

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

Interventions

hCG DRUG

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

Also known as: Pregnyl, Profasi

hCG given at time of GnRHa trigger

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Hypothalamic dysfunction, Patients with \< 14 follicles \< 11 mm in diameter, peak serum E2 levels \>= 4,000 pg/mL.

Sponsors & Collaborators

• UConn Health: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (6)

• Griffin D, Benadiva C, Kummer N, Budinetz T, Nulsen J, Engmann L. Dual trigger of oocyte maturation with gonadotropin-releasing hormone agonist and low-dose human chorionic gonadotropin to optimize live birth rates in high responders. Fertil Steril. 2012 Jun;97(6):1316-20. doi: 10.1016/j.fertnstert.2012.03.015. Epub 2012 Apr 3.

  PMID: 22480822 BACKGROUND

• Kummer N, Benadiva C, Feinn R, Mann J, Nulsen J, Engmann L. Factors that predict the probability of a successful clinical outcome after induction of oocyte maturation with a gonadotropin-releasing hormone agonist. Fertil Steril. 2011 Jul;96(1):63-8. doi: 10.1016/j.fertnstert.2011.04.050. Epub 2011 May 12.

  PMID: 21565337 BACKGROUND

• Engmann L, DiLuigi A, Schmidt D, Nulsen J, Maier D, Benadiva C. The use of gonadotropin-releasing hormone (GnRH) agonist to induce oocyte maturation after cotreatment with GnRH antagonist in high-risk patients undergoing in vitro fertilization prevents the risk of ovarian hyperstimulation syndrome: a prospective randomized controlled study. Fertil Steril. 2008 Jan;89(1):84-91. doi: 10.1016/j.fertnstert.2007.02.002. Epub 2007 Apr 26.

  PMID: 17462639 BACKGROUND

• Humaidan P. Luteal phase rescue in high-risk OHSS patients by GnRHa triggering in combination with low-dose HCG: a pilot study. Reprod Biomed Online. 2009 May;18(5):630-4. doi: 10.1016/s1472-6483(10)60006-5.

  PMID: 19549440 BACKGROUND

• Humaidan P, Bungum L, Bungum M, Yding Andersen C. Rescue of corpus luteum function with peri-ovulatory HCG supplementation in IVF/ICSI GnRH antagonist cycles in which ovulation was triggered with a GnRH agonist: a pilot study. Reprod Biomed Online. 2006 Aug;13(2):173-8. doi: 10.1016/s1472-6483(10)60612-8.

  PMID: 16895629 BACKGROUND

• Kaye 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 DERIVED

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome; Polycystic Ovary Syndrome

Interventions

Chorionic Gonadotropin; Profasi

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Ovarian Cysts; Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Results Point of Contact

• Title: Lawrence Engmann
• Organization: UConn Helth

lengmann@uchc.edu

8605258283

Study Officials

• Lawrence Engmann, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 16, 2013
• First Posted: March 20, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: October 26, 2018
• Results First Posted: September 25, 2017

Record last verified: 2018-09

Locations

US (1)