NCT00867763

Brief Summary

Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
1,440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 11, 2010

Status Verified

March 1, 2009

Enrollment Period

2.8 years

First QC Date

March 23, 2009

Last Update Submit

August 10, 2010

Conditions

Keywords

Polycystic ovaries,Tubal occlusionUnexplained infertilityLow ovarian reserveMale factor infertility

Outcome Measures

Primary Outcomes (1)

  • Cost effectiveness

    two years

Secondary Outcomes (1)

  • Ongoing pregnancy rates per cycle

    3 months

Study Arms (2)

IVM

EXPERIMENTAL

Early egg retrieval, in vitro maturation, then IVF

Procedure: In vitro maturation and in vitro fertilization

Mild IVF

ACTIVE COMPARATOR

Mild gonadotropin and conventional IVF

Procedure: Low doses of gonadotropin stimulation.

Interventions

No gonadotropin, eggs harvested early

Also known as: assisted reproduction
IVM

Gonadotropin followed by conventional IVF

Also known as: Assisted reproduction, IVF.
Mild IVF

Eligibility Criteria

Age21 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Under age 42 female, normal uterine cavity, BMI 18-34kg/m2,

You may not qualify if:

  • Donor eggs, donor sperm, myoma over 5 cm
  • Current hydrosalpinx, abnormal uterine cavity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Batzofin Fertilty Services

New York, New York, 10016, United States

Location

BFS

New York, New York, United States

Location

Related Publications (2)

  • Son WY, Chung JT, Herrero B, Dean N, Demirtas E, Holzer H, Elizur S, Chian RC, Tan SL. Selection of the optimal day for oocyte retrieval based on the diameter of the dominant follicle in hCG-primed in vitro maturation cycles. Hum Reprod. 2008 Dec;23(12):2680-5. doi: 10.1093/humrep/den332. Epub 2008 Sep 4.

    PMID: 18775885BACKGROUND
  • Son WY, Chung JT, Demirtas E, Holzer H, Sylvestre C, Buckett W, Chian RC, Tan SL. Comparison of in-vitro maturation cycles with and without in-vivo matured oocytes retrieved. Reprod Biomed Online. 2008 Jul;17(1):59-67. doi: 10.1016/s1472-6483(10)60294-5.

    PMID: 18616892BACKGROUND

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Interventions

Fertilization in Vitro

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Joe B Massey, MD

    Batzofin Fertility Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

August 11, 2010

Record last verified: 2009-03

Locations