IVF Treatment in Women With Immature Oocytes in Previous Cycle

NCT02368964 | Completed

• 1 other identifier: SHEBA-14-1817-YH-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

double triggering; Oocyte maturation; GNRH Agonist; hCG; IVF treatment; immature oocytes

Outcome Measures

Primary Outcomes (1)

• Number MII oocytes per number of oocytes retrieved

  Rate of mature oocytes from total oocytes retrieved

  day of retrieving the oocytes

Secondary Outcomes (3)

• Total oocytes

  day of retrieving the oocytes

• Pregnancy rate

  Two weeks from induction of ovulation

• Number of top quality embryos

  day of retrieving the oocytes

Study Arms (2)

High dose hCG

EXPERIMENTAL

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

Double trigger

EXPERIMENTAL

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

Interventions

GnRH agonist 0.2 mg + hCG 250 mcg DRUG

Treatment for triggering

Also known as: GnRH agonist - Decapeptyl , hCG - Ovitrelle

Double trigger

high dose hCG 500 mcg DRUG

Treatment for triggering

Also known as: Ovitrelle

High dose hCG

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (3)

• Lamb JD, Shen S, McCulloch C, Jalalian L, Cedars MI, Rosen MP. Follicle-stimulating hormone administered at the time of human chorionic gonadotropin trigger improves oocyte developmental competence in in vitro fertilization cycles: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2011 Apr;95(5):1655-60. doi: 10.1016/j.fertnstert.2011.01.019.

  PMID: 21315341 BACKGROUND

• Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.

  PMID: 23993928 BACKGROUND

• Zilberberg E, Haas J, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG, for final oocyte maturation (double trigger), in patients with low proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.

  PMID: 25385007 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropins; Placental Hormones; Pregnancy Proteins

Study Officials

• Aya Mohr Sasson, M.D

  Sheba Medical Center - IVF Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 23, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

IL (1)