Comapring Luteal Phase Support in IVF Patients Who Are at High Risk for Developing OHSS

NCT02827656 | Unknown DMC

• 1 other identifier: 056-16MMC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare two luteal support protocols in In vitro fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome (OHSS). We would like to determine whether luteal Decapeptyl on days 3, 6,9 post ovulation triggering is as good as low dose hCG on day 3 post triggering..

Conditions

Infertility

Keywords

Fertilization in vitro; Luteal Phase; ovarian hyperstimulation syndrome

Outcome Measures

Primary Outcomes (1)

• Progesterone serum level

  day 5 post ovum pickup

Secondary Outcomes (3)

• positive pregnancy test

  9-12 days post embryo transfer

• implantation rate

  30-33 days post embryo transfer

• clinical pregnancy rate

  30-33 days post embryo transfer

Study Arms (2)

Decapeptyl support

EXPERIMENTAL

S.C single luteal Decapeptyl 0.1 mg on days 3, 6,9 post ovulation triggering

Drug: Decapeptyl

hCG luteal support

ACTIVE COMPARATOR

S.C single luteal S.C recombinant hCG 50 micrograms on days 3 ovulation triggering

Drug: hCG luteal support

Interventions

Decapeptyl DRUG

luteal support as described and vaginal progesterone 200 mg 3 times a day

Decapeptyl support

hCG luteal support DRUG

luteal support as described and vaginal progesterone 200 mg 3 times a day

hCG luteal support

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• IVF treatment
• GnRH antagonist protocol
• GnRH agonist triggering of ovulation
• High risk for OHSS as expressed by either E2 serum level \>2500 pg/ml

You may not qualify if:

• background maternal morbidity
• Any protocol other than GnRH antagonist protocol
• hCG triggering of ovulation
• E2 serum level \>4500 pg/ml
• Aspiration of \>25 ova
• Embryo transfer prior to day 5

Sponsors & Collaborators

• Meir Medical Center: lead

Related Publications (6)

• Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.

  PMID: 21828116 BACKGROUND

• Youssef MA, Van der Veen F, Al-Inany HG, Mochtar MH, Griesinger G, Nagi Mohesen M, Aboulfoutouh I, van Wely M. Gonadotropin-releasing hormone agonist versus HCG for oocyte triggering in antagonist-assisted reproductive technology. Cochrane Database Syst Rev. 2014 Oct 31;2014(10):CD008046. doi: 10.1002/14651858.CD008046.pub4.

  PMID: 25358904 BACKGROUND

• Whelan JG 3rd, Vlahos NF. The ovarian hyperstimulation syndrome. Fertil Steril. 2000 May;73(5):883-96. doi: 10.1016/s0015-0282(00)00491-x.

  PMID: 10785212 BACKGROUND

• Humaidan P, Bredkjaer HE, Bungum L, Bungum M, Grondahl ML, Westergaard L, Andersen CY. GnRH agonist (buserelin) or hCG for ovulation induction in GnRH antagonist IVF/ICSI cycles: a prospective randomized study. Hum Reprod. 2005 May;20(5):1213-20. doi: 10.1093/humrep/deh765. Epub 2005 Mar 10.

  PMID: 15760966 BACKGROUND

• Griesinger G, Schultz L, Bauer T, Broessner A, Frambach T, Kissler S. Ovarian hyperstimulation syndrome prevention by gonadotropin-releasing hormone agonist triggering of final oocyte maturation in a gonadotropin-releasing hormone antagonist protocol in combination with a "freeze-all" strategy: a prospective multicentric study. Fertil Steril. 2011 May;95(6):2029-33, 2033.e1. doi: 10.1016/j.fertnstert.2011.01.163. Epub 2011 Mar 2.

  PMID: 21371705 BACKGROUND

• Kol S, Breyzman T, Segal L, Humaidan P. 'Luteal coasting' after GnRH agonist trigger - individualized, HCG-based, progesterone-free luteal support in 'high responders': a case series. Reprod Biomed Online. 2015 Dec;31(6):747-51. doi: 10.1016/j.rbmo.2015.09.001. Epub 2015 Sep 9.

  PMID: 26507279 BACKGROUND

MeSH Terms

Conditions

Infertility; Ovarian Hyperstimulation Syndrome

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; 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

Study Officials

• Amir Wiser, MD

  MMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Klement, MD

CONTACT

anat.klement@gmail.com

Helsinki Committee MMC

CONTACT

97297471588

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 11, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 12, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share