Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
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Purpose
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Hyperstimulation Syndrome |
Drug: Triptorelin 0.2 mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS |
- Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval. [ Time Frame: 12 day from GnRH agonist trigger day. ] [ Designated as safety issue: Yes ]OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.
- Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta. [ Time Frame: One month from embryo transfer date ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: OHSS high risk patients
Triptorelin 0.2 mg
|
Drug: Triptorelin 0.2 mg
A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.
Other Name: Decapeptyl 0.2 mg
|
Detailed Description:
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final oocyte maturation after ovarian stimulation. In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.
An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG. This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.
It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would require alternative luteal phase support to secure good clinical outcome. Alternatively, good quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS due to pregnancy.
Eligibility| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A female patient who needs IVF to become pregnant.
- Regular menstrual cycle.
- Antral follicular count (AFC) > 18
- Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the medications used.
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
- Pregnancy.
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Primary ovarian failure.
- Ovarian cysts or enlarged ovaries.
- A history of Ovarian Hyperstimulation Syndrome (OHSS).
- A previous COS cycle that resulted in more than 30 follicles > 11 mm measured by ultrasound examination.
- Fibroid tumours of the uterus incompatible with pregnancy.
- Malformations of the reproductive organs incompatible with pregnancy
Contacts and Locations| Contact: Shahar Kol, MD | 972502064126 | ivfisrael@gmail.com |
| Contact: Joseph Itskovitz, MD | 972-50-2062035 | itskovitz@gmail.com |
| Israel | |
| IVF Unit, Elisha Hospital | Not yet recruiting |
| Haifa, Israel, 31064 | |
| Contact: Shahar Kol, MD 972502064126 ivfisrael@gmail.com | |
| Contact: Joseph Itskovitz, MD 972502062035 itskovitz@gmail.com | |
| Principal Investigator: Shahar Kol, MD | |
| Principal Investigator: | Shahar Kol, MD | Elisha Hospital, Haifa, Israel |
More Information
No publications provided
| Responsible Party: | Dr. Shahar Kol, Principal Investigator, Elisha Hospital |
| ClinicalTrials.gov Identifier: | NCT01714648 History of Changes |
| Other Study ID Numbers: | MSD-ELISHA1, 8328-086 |
| Study First Received: | October 20, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Elisha Hospital:
|
OVULATION INDUCTION |
Additional relevant MeSH terms:
|
Ovarian Hyperstimulation Syndrome Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Triptorelin Deslorelin Luteolytic Agents Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013