Clinical trial NCT00675142: Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Intra-uterine insemination
ovarian stimulation
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Achieving pregnancy
timeFrame: 2 weeks after intervention
Secondary outcomes:
measure: Live Birth
timeFrame: 9 months after interventio
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: haemek medical center
name: Amir Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.fertnstert.2004.02.101.
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. doi: 10.1056/NEJM199901213400302.
citation: 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.