NCT00963625

Brief Summary

This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration 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

Study Start

First participant enrolled

October 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

3 years

First QC Date

August 19, 2009

Last Update Submit

October 8, 2010

Conditions

Infertility

Keywords

Blastocyst transferendometrial receptivityIVFin vitro fertilizationembryo cryopreservation

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)

    7 weeks gestation

Secondary Outcomes (2)

  • Ongoing pregnancy at 10 weeks gestation

    10 weeks gestation

  • Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)

    7 weeks gestation

Study Arms (2)

Blastocyst transfer in PTEC cycle

EXPERIMENTAL

Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).

Procedure: Embryo cryopreservation

Fresh blastocyst transfer.

ACTIVE COMPARATOR

Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.

Procedure: Fresh blastocyst transfer

Interventions

Embryo cryopreservationPROCEDURE

Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.

Blastocyst transfer in PTEC cycle
Fresh blastocyst transferPROCEDURE

Fresh blastocyst transfer following cycle of controlled ovarian stimulation.

Fresh blastocyst transfer.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female patient 18 to 40 years of age seeking their first IVF treatment.
  • Cycle day 3 FSH less than 10.0 IU/l.
  • to 15 antral follicles observed on ultrasound.

You may not qualify if:

  • Failure to follow the protocol.
  • Embryo biopsy.
  • Any prior IVF cycle(s).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

Location

Related Publications (3)

  • Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.

    PMID: 33539543DERIVED

  • Shapiro BS, Daneshmand ST, Bedient CE, Garner FC. Comparison of birth weights in patients randomly assigned to fresh or frozen-thawed embryo transfer. Fertil Steril. 2016 Aug;106(2):317-21. doi: 10.1016/j.fertnstert.2016.03.049. Epub 2016 Jul 7.

    PMID: 27397626DERIVED

  • Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.

    PMID: 21737072DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Bruce Shapiro, M.D., Ph.D.

    Fertility Center of Las Vegas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 21, 2009

Study Start

October 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

US(1)