InfertilityNCT00675142
Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists
A study testing Intrauterine Insemination in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Intrauterine Insemination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with
- Ovulatory disorder
- male factor
- partial mechanical factor
- endometriosis
- unexplained infertility.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Intrauterine Insemination
- Keywords
- Infertility, Intra-uterine insemination, ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine InseminationProcedure or surgery
Changing the time span between ovulation induction and IUI during fertility treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IUI 36 hours after ovulation induction Receives: Procedure: Intrauterine Insemination |
| 2 | Experimental | IUI 42 hours after ovulation induction Receives: Procedure: Intrauterine Insemination |
| 3 | Experimental | IUI 48 hours after ovulation induction Receives: Procedure: Intrauterine Insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving pregnancy
Measured: 2 weeks after intervention
Secondary outcomes (1)
Live Birth
Measured: 9 months after interventio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Weiss, HaEmek Medical Center, Israel
- Investigators
- Amir Weiss, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675142
- Sponsor's protocol ID
- 5-08EMC.CTIL
- Status last verified
- Jun 2015
- First submitted
- 7 May 2008
- Last updated
- 23 Jun 2015
- Results posted
- No
Publications
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.
PubMed 15236983Guzick 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.
PubMed 9895397Gomez-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.
PubMed 15567879
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00675142
- Acronym / sponsor ID
- 5-08EMC.CTIL
- Conditions
- Infertility
- Keywords
- Infertility, Intra-uterine insemination, ovarian stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Intrauterine InseminationIUI 36 hours after ovulation induction |
| 2 | Experimental | Procedure: Intrauterine InseminationIUI 42 hours after ovulation induction |
| 3 | Experimental | Procedure: Intrauterine InseminationIUI 48 hours after ovulation induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with
- Ovulatory disorder
- male factor
- partial mechanical factor
- endometriosis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine InseminationChanging the time span between ovulation induction and IUI during fertility treatment. | Procedure or surgery | 1, 2, 3 |
Primary outcome
Achieving pregnancy
Time frame: 2 weeks after intervention
1 secondary outcome
Live Birth
Time frame: 9 months after interventio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Background: PubMed 15236983Guzick 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.
- Background: PubMed 9895397Guzick 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.
- Background: PubMed 15567879Gomez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Weiss, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Insemination in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving pregnancy (time frame: 2 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675142, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.