NCT00799929

Brief Summary

The purpose of this study is to compare two different in vitro fertilization (IVF) treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
564

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

5.4 years

First QC Date

November 26, 2008

Last Update Submit

December 22, 2015

Conditions

Infertility

Keywords

IVF Research StudyInfertility Sudyin vitro fertilizationMini IVFConventional IVF

Outcome Measures

Primary Outcomes (1)

  • Primary outcome parameter: Live birth

    4 Years

Secondary Outcomes (1)

  • Secondary outcome parameters: Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Multiple pregnancy rate, Miscarriage rate, Fertilization rate, Number of oocytes, Number of embryos

    4 Years

Study Arms (2)

ARM A - Mini IVF

ACTIVE COMPARATOR

The Mini IVF method entails pre-treatment with oral contraceptive pills. Ovarian stimulation is achieved using an oral anti-estrogen in conjunction with injections of gonadotropin (225IU-600IU per cycle), with initial dose of 75IU-150IU per injection. Ovulation is induced by a GnRH (gonadotropin-releasing hormone) agonist nasal spray/hCG (human chorionic gonadotropin) injection. Retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. Blastocyst stage embryos are vitrified using the CryoTop method. No fresh embryo transfer is conducted. Subsequently, SET of a thawed blastocyst is performed in a natural cycle/HRT that does not involve ovarian stimulation. SETs are conducted until pregnancy is achieved or all vitrified blastocysts have been used.

Other: in vitro fertilization (IVF/ICSI)

Arm B - Conventional IVF

ACTIVE COMPARATOR

The standard IVF method entails pre-treatment with a GnRH analog injections in the midluteal phase. Controlled ovarian hyperstimulation is achieved with injections of gonadotropin (150IU-300IU/day). Ovulation is induced by hCG injection and retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. If this occurs on day 5, then fresh SET/DET (single embryo transfer/double embryo transfer) is performed. Remaining blastocysts are cryopreserved and transferred in subsequent natural cycles/HRT (hormone replacement therapy) that does not involve ovarian stimulation.

Other: in vitro fertilization (IVF/ICSI)

Interventions

in vitro fertilization (IVF/ICSI)OTHER
ARM A - Mini IVFArm B - Conventional IVF

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Valid indication for IVF treatment
  • First IVF attempt
  • Female age between 18 and 38 years
  • Male partner 18 years of age or older
  • Both partners STD free
  • Must be able to understand that they may NOT become pregnant

You may not qualify if:

  • Not willing or able to sign the consent form
  • Pre-existing medical condition preventing/interfering with IVF treatment
  • Abnormal IVF screening tests, which includes Complete Blood Count, Varicella titer, Rubella titer, PAP smear, Syphilis, HIV 1\&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea
  • Abnormal pap smear
  • Body Mass Index (BMI) falls below 18.5 or above 32.0
  • Female participant with irregular menstrual cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Hope Fertility Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Zhang JJ, Yang M, Merhi Z. Efficiency of metaphase II oocytes following minimal/mild ovarian stimulation in vitro fertilization. Fertil Res Pract. 2016 Sep 1;2:2. doi: 10.1186/s40738-016-0025-6. eCollection 2016.

    PMID: 28620528DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Fertilization in Vitro

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • John J Zhang, MD, MSc, PhD

    New Hope Fertility Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2008

First Posted

December 1, 2008

Study Start

December 1, 2008

Primary Completion

May 1, 2014

Study Completion

October 1, 2014

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(1)