Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study

NCT01921166 | Completed Phase 4 Results DMC

• 1 other identifier: Diminished Ovarian Reserve
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is (A) to determine if the following novel approach improves the live birth rate with In-Vitro Fertilization (IVF) for women with a poor prognosis due to diminished ovarian reserve:

• ovarian stimulation with medications that are effective in women with diminished ovarian reserve but adversely affect the endometrium
• oocyte retrieval and vitrification
• fertilization and embryo transfer in a subsequent cycle with controlled endometrial preparation B) To determine the optimal stimulation protocol for women with diminished ovarian reserve incorporating oocyte vitrification Women who are not eligible to participate in the Carolinas Medical Center (CMC) Assisted Reproductive Therapy program because of an extremely poor prognosis will be recruited for a prospective, randomized, open-label study to determine if a novel approach improves the live birth rate with traditional IVF "poor prognosis" stimulation protocols. The novel approach will incorporate one of two protocols utilizing medications that provide maximal ovarian stimulation but have a temporary detrimental fertility-reducing effect on the endometrium. If ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes vitrified (stored in a "glass-like" state in liquid nitrogen). At a later time, oocyte warming and fertilization will be performed in a subsequent cycle, in which the endometrium has been prepared. Key points include:
• Randomization to one of two ovarian stimulation protocols that have been shown to have a detrimental effect on the endometrium, and therefore are rarely used in a "fresh" IVF cycle
• Oocyte vitrification is considered to be an investigational procedure by the American Society of Reproductive Medicine (ASRM), and should only be performed under the supervision of an IRB. With oocyte vitrification, ovarian stimulation and oocyte retrieval can "unlinked" from embryo transfer, allowing embryo transfer to occur in a more optimal environment
• Endometrial preparation is routine for frozen embryo transfer

Conditions

Infertility

Keywords

infertility; diminished ovarian reserve; fertilization in vitro; ovulation inducion; vitrification

Outcome Measures

Primary Outcomes (1)

• Oocytes

  Number of oocytes retrieved

  up to 24 months

Secondary Outcomes (1)

• Number of Oocytes Vitrified

  up to 24 months

Other Outcomes (1)

• Number of Embryos From Vitrified Oocytes

  up to 24 months

Study Arms (2)

clomiphene plus gonadotropins

ACTIVE COMPARATOR

clomiphene plus gonadotropins

Drug: clomiphene plus gonadotropins

Leuprolide flare

ACTIVE COMPARATOR

Leuprolide flare

Drug: Leuprolide flare

Interventions

clomiphene plus gonadotropins DRUG

clomiphene plus gonadotropin ovulation induction

Also known as: Clomid. Serophene. Gonal f. Bravelle. Follistim. Menopur.

clomiphene plus gonadotropins

Leuprolide flare DRUG

Leuprolide flare ovulation induction

Also known as: Lupron.

Leuprolide flare

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Basal FSH 17 IU/mL (highest ever)
• Basal FSH 15-17 (highest ever) and failed EFORT test
• Age \> 43 at the time of expected retrieval
• Failure to conceive with a prior "poor prognosis" IVF stimulation protocol (microdose leuprolide flare or GnRH antagonist cycle) if administered because of evidence of diminished ovarian reserve
• Failure to conceive with 3 or more IVF cycles at CMC

You may not qualify if:

• Contraindications to IVF
• Contraindication to pregnancy
• Allergy or contraindication to medications used for IVF or embryo transfer
• Use for a gestational carrier
• Uncorrected or untreatable uterine infertility
• Smoking or substance abuse within 3 months of initiating stimulation for IVF

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene; Gonadotropins; Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Bradley Hurst, M.D., Director of Assisted Reproduction
• Organization: AtriumHealth

brad.hurst@atriumhealth.org

704-355-3149

Study Officials

• Bradley S Hurst, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 13, 2013
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2014
• Last Updated: August 2, 2024
• Results First Posted: February 23, 2018

Record last verified: 2021-06