NCT02251925

Brief Summary

This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2012

Enrollment Period

3.1 years

First QC Date

September 23, 2014

Last Update Submit

May 5, 2015

Conditions

Infertility

Keywords

infertility froze emberyo transfer hormone replacement

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.

    4 weeks

Secondary Outcomes (4)

  • Implantation rate

    4 weeks

  • chemical pregnancy rates

    2 weeks

  • Ongoing pregnancy

    12 weeks

  • miscarriage rate

    12 weeks

Study Arms (4)

Natural cycle

EXPERIMENTAL

In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.

Biological: frozen Embryo transfer

Natural cycle + hCG for ovulation induction

EXPERIMENTAL

In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.

Biological: frozen Embryo transferDrug: 10,000U hCG injection

Hormonally controlled cycle with GnRH-a

EXPERIMENTAL

In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.

Biological: frozen Embryo transferDrug: GnRH agonist (Superfact)

Hormonally controlled cycle without GnRH-a

EXPERIMENTAL

In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.

Biological: frozen Embryo transferDrug: administration of 6 mg Estradiol valerate

Interventions

frozen Embryo transferBIOLOGICAL

In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).

Hormonally controlled cycle with GnRH-aHormonally controlled cycle without GnRH-aNatural cycleNatural cycle + hCG for ovulation induction
10,000U hCG injectionDRUG

In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.

Natural cycle + hCG for ovulation induction
GnRH agonist (Superfact)DRUG

In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.

Hormonally controlled cycle with GnRH-a
administration of 6 mg Estradiol valerateDRUG

In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.

Hormonally controlled cycle without GnRH-a

Eligibility Criteria

Age20 Years - 37 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with regular mensturation cycles
  • Age 20-37 years
  • Patients who underwent long protocol
  • Body mass index (BMI) ≤ 30 kg/m2
  • Patients who will undergo frozen embryo transfer for the first time

You may not qualify if:

  • Oocyte or embryo donation cycles
  • Uterine diseases or malformations
  • Hyper prolactinemia
  • Thyroid disorders
  • Tuberculosis
  • Recurrent abortion history
  • Severe endometriosis
  • Ovulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

RECRUITING

Related Publications (1)

  • Madani T, Ramezanali F, Yahyaei A, Hasani F, Bagheri Lankarani N, Mohammadi Yeganeh L. Live birth rates after different endometrial preparation methods in frozen cleavage-stage embryo transfer cycles: a randomized controlled trial. Arch Gynecol Obstet. 2019 Apr;299(4):1185-1191. doi: 10.1007/s00404-019-05062-7. Epub 2019 Feb 1.

    PMID: 30707360DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing HormoneEstradiol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Tahereh Madani, MD

    Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

    STUDY DIRECTOR

  • Ladan Mohammadi Yeganeh, MSC

    Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Aghdami, MD,PhD

CONTACT

(+98)23562000nasser.aghdami@royaninstitute.org

Leila Arab, MD

CONTACT

(+98)23562000Leara91@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 29, 2014

Study Start

September 1, 2012

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

May 6, 2015

Record last verified: 2012-04

Locations

IR(1)