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Replacement of Fresh Embryo Transfers (ETs) by Frozen Embryo Transfers (FETs) Using Vitrification

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Yazd Research & Clinical Center for Infertility.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier:
NCT00823121
First received: January 14, 2009
Last updated: January 19, 2010
Last verified: April 2009
  Purpose

Cryopreservation of all embryos and transferring them subsequently in assisted reproductive technology (ART) cycles to improve outcome.


Condition Intervention Phase
In Vitro Fertilization
Procedure: freezing embryos by vitrification
Procedure: fresh embryo transfers
Drug: buserelin
Drug: recombinant FSH
Drug: human chorionic gonadotropin (pregnyl)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Fresh Embryo Transfers be Replaced by Cryopreserved-thawed Embryo Transfers in Assisted Reproductive Cycles?

Resource links provided by NLM:


Further study details as provided by Yazd Research & Clinical Center for Infertility:

Primary Outcome Measures:
  • implantation rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • on going pregnancy rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: frozen-embryo transfer
In this group all embryos are cryopreserved and two months later embryo transfer will perform.
Procedure: freezing embryos by vitrification
vitrification by Cryotop method
Other Name: cryopreservation of embryos
Drug: buserelin
Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.
Other Name: suprefact
Drug: recombinant FSH
gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle
Other Name: Gonal F
Drug: human chorionic gonadotropin (pregnyl)
hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.
Other Name: pregnyl
Active Comparator: fresh embryo transfer
In this arm fresh embryo transfers are performed on day 2 or 3.
Procedure: fresh embryo transfers
fresh embryo transfers
Other Name: embryo transfer using fresh embryos
Drug: buserelin
Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.
Other Name: suprefact
Drug: recombinant FSH
gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle
Other Name: Gonal F
Drug: human chorionic gonadotropin (pregnyl)
hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.
Other Name: pregnyl

Detailed Description:

All patients in the initial cohort were treated with long protocol for ovarian stimulation. For pituitary down-regulation, patients were treated with daily administration of 0.5 mg buserelin (suprefact, Aventis, Frankfurt, Germany) from day 21 of menstrual cycle. Buserelin was reduced to 0.25 mg daily when ovaries were quiescent on ultrasound, and COH was initiated with recombinant FSH (Gonal F, Serono, Aubnne, Switzerland) 150 IU/day on day 2 of withdrawal bleeding. Serial ultrasound examinations and evaluation of serum E2 levels were used to assess ovarian response, and then gonadotropin dose adjustments were done as required. Human chorionic gonadotropin (pregnyl, Organon, Oss, the Netherlands ) 10,000 IU was administered when at least two follicles reached a mean diameter of 18 mm.

Oocyte retrieval was performed 34-36 hours after hCG administration and conventional insemination or ICSI was performed as clinically appropriate.

In 187 patients allocated to fresh ET group, ET were performed on the day 2. Embryos were transferred under ultrasound guidance, with a C.C.D. embryo transfer catheter (Laboratory C.C.D., Paris, France). Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 100 mg daily IM was started on the day of oocyte retrieval and continued until the documentation of fetal heart activity on ultrasound.

In 187 patients allocated to FET group, cryopreservation of all embryos were undertaken with vitrification by Cryotop method and after two months, embryos were transferred.

The protocol for the Cryotop vitrification of embryos was described previously (Kuwayama et al., 2005; Kuwayama, 2007).

After a two-step loading with equilibration solution containing 7.5% (v/v) ethylene glycol and 7.5% (v/v) dimethyl sulfoxide, and vitrification solution containing 15% (v/v) ethylene glycol, 15% (v/v) dimethyl sulfoxide and 0.5 mol/L sucrose, embryos were loaded with a narrow glass capillary onto the Cryotop in a volume of < 0.1 µL . After loading, almost all the solution was removed to leave only a thin layer covering the embryos, and the sample was quickly immersed into liquid nitrogen (LN). Subsequently, the plastic cap was pulled over the film part of the Cryotop, and the sample was stored under LN. At warming, the protective cap was removed from the Cryotop while it was still submerged in LN and the Cryotop was immersed directly into a 37˚C medium containing sucrose. The embryos were then sequentially incubated in diluents solution before further in vitro culture for transfer.

Patients were prepared for ET with oral E2 to attain endometrial thickness ≥ 8 mm and triple line pattern on ultrasound scans. At that time, patients were given 100 mg of IM progesterone in oil daily and ET was preformed three days later under abdominal ultrasound guidance as described earlier. Oral E2 and progesterone were continued until documentation of fetal heart activity by ultrasonography.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age < 38
  • normal day 3 FSH
  • classified as high risk for OHSS
  • has ≥ 15 follicles with a mean diameter ≥ 12 mm per each ovary
  • E2 levels on the day of hCG administration > 3000 pg/mL
  • undergoing her first assisted reproduction treatment cycle

Exclusion Criteria:

  • who does not have good-quality embryos appropriate for cryopreservation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823121

Contacts
Contact: homa oskouian, Dr 3518247085 ext +98 homaoskouian@gmail.com
Contact: abbas aflatoonian, Dr 9151119557 ext +98 abbas_aflatoonian@yahoo.com

Locations
Iran, Islamic Republic of
: Research and clinical center for infertility Recruiting
Yazd, Iran, Islamic Republic of, 8916877391
Contact: homa oskouian, Dr    8247085 ext +98351    homaoskouian@gmail.com   
Principal Investigator: homa oskouian, Dr         
Principal Investigator: abbas aflatoonian, professor         
Sponsors and Collaborators
Yazd Research & Clinical Center for Infertility
Investigators
Principal Investigator: abbas aflatoonian, M.D. Research and Clinical Center for Infertility
Principal Investigator: homa oskouian, M.D. Research and Clinical Center for Infertility
  More Information

No publications provided by Yazd Research & Clinical Center for Infertility

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: abbas,aflatoonian, YazdRCCI
ClinicalTrials.gov Identifier: NCT00823121     History of Changes
Other Study ID Numbers: 654YazdRCCI
Study First Received: January 14, 2009
Last Updated: January 19, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Yazd Research & Clinical Center for Infertility:
Fresh embryo transfer
frozen- thawed embryo transfer
vitrification
endometrial receptivity
implantation rate
pregnancy
ART

Additional relevant MeSH terms:
Buserelin
Chorionic Gonadotropin
Fertility Agents
Fertility Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014