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

NCT ID: NCT00823121

Last Updated: 2010-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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frozen-embryo transfer

In this group all embryos are cryopreserved and two months later embryo transfer will perform.

Group Type ACTIVE_COMPARATOR

freezing embryos by vitrification

Intervention Type PROCEDURE

vitrification by Cryotop method

buserelin

Intervention Type DRUG

Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.

recombinant FSH

Intervention Type DRUG

gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle

human chorionic gonadotropin (pregnyl)

Intervention Type DRUG

hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.

fresh embryo transfer

In this arm fresh embryo transfers are performed on day 2 or 3.

Group Type ACTIVE_COMPARATOR

fresh embryo transfers

Intervention Type PROCEDURE

fresh embryo transfers

buserelin

Intervention Type DRUG

Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.

recombinant FSH

Intervention Type DRUG

gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle

human chorionic gonadotropin (pregnyl)

Intervention Type DRUG

hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.

Interventions

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freezing embryos by vitrification

vitrification by Cryotop method

Intervention Type PROCEDURE

fresh embryo transfers

fresh embryo transfers

Intervention Type PROCEDURE

buserelin

Daily administration of 500 µg subcutaneous buserelin from day 21 of menstrual cycle; reduce to 250 µg daily when ovarian suppression is confirmed.

Intervention Type DRUG

recombinant FSH

gonadotropin stimulation with rFSH 150 IU/day from day 2 of menstrual cycle

Intervention Type DRUG

human chorionic gonadotropin (pregnyl)

hCG 10,000 IU is administered when at least 2 follicles reach a mean diameter of 18 mm.

Intervention Type DRUG

Other Intervention Names

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cryopreservation of embryos embryo transfer using fresh embryos suprefact Gonal F pregnyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yazd Research & Clinical Center for Infertility

OTHER

Sponsor Role lead

Responsible Party

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YazdRCCI

Principal Investigators

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abbas aflatoonian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Research and Clinical Center for Infertility

homa oskouian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Research and Clinical Center for Infertility

Locations

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: Research and clinical center for infertility

Yazd, Yazd Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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homa oskouian, Dr

Role: CONTACT

3518247085 ext. +98

abbas aflatoonian, Dr

Role: CONTACT

9151119557 ext. +98

Facility Contacts

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homa oskouian, Dr

Role: primary

8247085 ext. +98351

References

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Aflatoonian A, Oskouian H, Ahmadi S, Oskouian L. Can fresh embryo transfers be replaced by cryopreserved-thawed embryo transfers in assisted reproductive cycles? A randomized controlled trial. J Assist Reprod Genet. 2010 Jul;27(7):357-63. doi: 10.1007/s10815-010-9412-9. Epub 2010 Apr 6.

Reference Type DERIVED
PMID: 20373015 (View on PubMed)

Other Identifiers

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654YazdRCCI

Identifier Type: -

Identifier Source: org_study_id

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