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IVF Treatment in Women With Immature Oocytes in Previous Cycle

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ClinicalTrials.gov Identifier: NCT02368964
Recruitment Status : Recruiting
First Posted : February 23, 2015
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

Brief Summary:

In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually given between 12-24 hours before the hCG triggering dose.One protocol used at the investigators unit, after a cycle with low proportion of mature oocytes per number oocytes retrieved, is triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration.

Lately, new researches showed that dual triggering of final oocyte maturation with a combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders undergoing the GnRH-antagonist COH protocol

Another treatment option is high dose hCG. Only few case reports have described the use of high dose hCG after aspiration of non mature oocytes at a previous cycle. At the investigators IVF unit, patients with previous history of high percentage of immature oocytes retrieved, are triggered at the following cycle, either with double trigger or with high dose of hCG decided by the physician consulting the patient. It is still not known with which way of triggering more mature oocytes is retrieved.

The aim of this study is to perform a prospective randomized controlled study in patients with low proportion of mature-MII oocytes oocytes (<75%) per number oocytes retrieved, despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles triggered with high dose hCG to those triggered with hCG+GnRH agonist.


Condition or disease Intervention/treatment Phase
Infertility Drug: GnRH agonist 0.2 mg + hCG 250 mcg Drug: high dose hCG 500 mcg Not Applicable

Detailed Description:

Patients will be prospectively randomized into two groups. The randomization will be organized through the computer. The hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration, and the Double trigger Group- will receive gonadotropin-releasing hormone (GnRH) agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration. All patients will be supplemented with the same progesterone preparation( Crinone gel 8% once a day) for luteal support. Women that suffer from vaginal spotting or vaginal bleeding during the luteal phase will receive supplementation of Geston 50MG intramuscular once every 2 days.

At the day of oocyte aspiration, blood will be drawn for serum LH, FSH, estrogen (E2) and progesterone. Moreover, clear follicular fluid will be collected and tested for LH, FSH, E2 and progesterone levels.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment for Final Follicular Maturation Induction in Patients With Previous High Ratio of Immature Oocytes
Actual Study Start Date : February 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose hCG
The hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration
Drug: high dose hCG 500 mcg
Treatment for triggering
Other Name: Ovitrelle

Experimental: Double trigger
Double trigger Group- will receive GnRH agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration
Drug: GnRH agonist 0.2 mg + hCG 250 mcg
Treatment for triggering
Other Name: GnRH agonist - Decapeptyl , hCG - Ovitrelle




Primary Outcome Measures :
  1. Number MII oocytes per number of oocytes retrieved [ Time Frame: day of retrieving the oocytes ]
    Rate of mature oocytes from total oocytes retrieved


Secondary Outcome Measures :
  1. Total oocytes [ Time Frame: day of retrieving the oocytes ]
  2. Pregnancy rate [ Time Frame: Two weeks from induction of ovulation ]
  3. Number of top quality embryos [ Time Frame: day of retrieving the oocytes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with low proportion of mature-MII oocytes oocytes (75%) per number oocytes retrieved at the prior IVF cycle
  • Age between 18-42

Exclusion Criteria:

  • Women with high ovarian response:anti-mullerian hormone ( AMH) >5, antral follicle count ( AFC) >15
  • more than 20 oocytes retrieved at the prior cycle.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368964


Contacts
Contact: Aya Mohr Sasson, M.D mohraya@gmail.com
Contact: Eve Keret Eve.Keret@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Aya Mohr Sasson, M.D Sheba Medical Center - IVF Unit

Additional Information:
Publications:
Responsible Party: Dr. Aya Mohr-Sasson, Doctor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02368964     History of Changes
Other Study ID Numbers: SHEBA-14-1817-YH-CTIL
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
double triggering
Oocyte maturation
GNRH Agonist
hCG
IVF treatment
immature oocytes

Additional relevant MeSH terms:
Infertility
Chorionic Gonadotropin
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents