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

Infertility Clinical Trial

Official title:

A Randomized Open Three Arm Prospective Trial To Determine The Optimal Timing for Intrauterine Insemination After Superovulation With Recombinant Gonadotropins Utilizing GnRH Antagonists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675142
• Other study ID #: 5-08EMC.CTIL
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: June 21, 2015
• Start date: May 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Intrauterine Insemination
Changing the time span between ovulation induction and IUI during fertility treatment.

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Gómez-Palomares JL, Juliá B, Acevedo-Martín B, Martínez-Burgos M, Hernández ER, Ricciarelli E. Timing ovulation for intrauterine insemination with a GnRH antagonist. Hum Reprod. 2005 Feb;20(2):368-72. Epub 2004 Nov 26. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving pregnancy		2 weeks after intervention	No
Secondary	Live Birth		9 months after interventio	No