Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists

NCT ID: NCT00675142

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-08-31

Brief Summary

The timing of IUI following ovulation induction has been the subject of many studies and a consensus has developed that a single insemination approximately thirty-six hours after ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature LH surge and early ovulation has added a new dimension to fertility treatment. It allows greater accuracy in predicting the timing of ovulation and has been shown to be at least as effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released from the ovary. We therefore propose a randomized open three arm prospective trial utilizing superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48 hours after ovulation induction.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

IUI 36 hours after ovulation induction

Group Type: EXPERIMENTAL

Intrauterine Insemination

Intervention Type: PROCEDURE

Changing the time span between ovulation induction and IUI during fertility treatment.

2

IUI 42 hours after ovulation induction

Group Type: EXPERIMENTAL

Intrauterine Insemination

Intervention Type: PROCEDURE

Changing the time span between ovulation induction and IUI during fertility treatment.

3

IUI 48 hours after ovulation induction

Group Type: EXPERIMENTAL

Intrauterine Insemination

Intervention Type: PROCEDURE

Changing the time span between ovulation induction and IUI during fertility treatment.

Interventions

Intrauterine Insemination

Changing the time span between ovulation induction and IUI during fertility treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with
• Ovulatory disorder
• male factor
• partial mechanical factor
• endometriosis
• unexplained infertility.

Exclusion Criteria

• Known allergy to one or more of the utilized drugs
• Neither fallopian tube is patent
• Sperm count less than 1 million total motile sperm of normal morphology during at least two investigations
• Women who are candidates for mono-ovulation.
• failure to receive consent
• women with baseline functional cysts (i.e. hormone producing) above 12 mm diameter.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Amir Weiss

Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

HaEmek Medical Center

Afula, , Israel

Countries

Israel

References

Guzick DS. For now, one well-timed intrauterine insemination is the way to go. Fertil Steril. 2004 Jul;82(1):30-1; discussion 32-5. doi: 10.1016/j.fertnstert.2004.02.101.

Reference Type: BACKGROUND

PMID: 15236983 (View on PubMed)

Guzick DS, Carson SA, Coutifaris C, Overstreet JW, Factor-Litvak P, Steinkampf MP, Hill JA, Mastroianni L, Buster JE, Nakajima ST, Vogel DL, Canfield RE. Efficacy of superovulation and intrauterine insemination in the treatment of infertility. National Cooperative Reproductive Medicine Network. N Engl J Med. 1999 Jan 21;340(3):177-83. doi: 10.1056/NEJM199901213400302.

Reference Type: BACKGROUND

PMID: 9895397 (View on PubMed)

Gomez-Palomares JL, Julia B, Acevedo-Martin B, Martinez-Burgos M, Hernandez ER, Ricciarelli E. Timing ovulation for intrauterine insemination with a GnRH antagonist. Hum Reprod. 2005 Feb;20(2):368-72. doi: 10.1093/humrep/deh602. Epub 2004 Nov 26.

Reference Type: BACKGROUND

PMID: 15567879 (View on PubMed)

Other Identifiers

5-08EMC.CTIL

Identifier Type: -

Identifier Source: org_study_id