EndometriosisNCT01334762
Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis
A study testing Letrozole/IUI and CC/IUI in people with Endometriosis, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis. Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Letrozole/IUI and CC/IUI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- May 2007to Jun 2010
- 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 20 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure
- No other infertility factors.
- Normal serum basal hormone levels as well as documented ovulation
Who cannot join
- Moderate or severe endometriosis
- Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery
- Age more than 36 years, BMI more than 30 kg/m2
- women with a previous pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis
To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.
- Conditions
- Endometriosis
- Being tested
- Letrozole/IUI, CC/IUI
- Keywords
- minimal to mild endometriosis, letrozole, clomiphene citrate, IUI
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole/IUIDrug
Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.
CC/IUIDrug
Patients received 100 mg lCC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole/IUI | Experimental | Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment. Receives: Drug: Letrozole/IUI |
| CC/IUI | Active comparator | Patients received 100 mg CC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment. Receives: Drug: CC/IUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate per cycle
Measured: 6-7 weeks gestation
Secondary outcomes (1)
Miscarriage rate.
Measured: Up to 20 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMay 2007
- Primary completionJun 2010
- Study completionJun 2010
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 EndometriosisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- Hatem Abu Hashim, MD MRCOG, Principal investigator, Mansoura University HospitalMohamed El Rakhawy, MD, Study chair, Mansoura University HospitalIbrahim Abd Elaal, Study director, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334762
- Sponsor's protocol ID
- MU-157x
- Other IDs
- FMH-92-B
- Status last verified
- Apr 2011
- First submitted
- 11 Apr 2011
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dmowski WP, Pry M, Ding J, Rana N. Cycle-specific and cumulative fecundity in patients with endometriosis who are undergoing controlled ovarian hyperstimulation-intrauterine insemination or in vitro fertilization-embryo transfer. Fertil Steril. 2002 Oct;78(4):750-6. doi: 10.1016/s0015-0282(02)03343-5.
PubMed 12372451Werbrouck E, Spiessens C, Meuleman C, D'Hooghe T. No difference in cycle pregnancy rate and in cumulative live-birth rate between women with surgically treated minimal to mild endometriosis and women with unexplained infertility after controlled ovarian hyperstimulation and intrauterine insemination. Fertil Steril. 2006 Sep;86(3):566-71. doi: 10.1016/j.fertnstert.2006.01.044.
PubMed 16952506Abu Hashim H, El Rakhawy M, Abd Elaal I. Randomized comparison of superovulation with letrozole vs. clomiphene citrate in an IUI program for women with recently surgically treated minimal to mild endometriosis. Acta Obstet Gynecol Scand. 2012 Mar;91(3):338-45. doi: 10.1111/j.1600-0412.2011.01346.x. Epub 2012 Jan 26.
PubMed 22181973
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis
- ClinicalTrials.gov ID
- NCT01334762
- Acronym / sponsor ID
- MU-157x
- Conditions
- Endometriosis
- Keywords
- minimal to mild endometriosis, letrozole, clomiphene citrate, IUI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Apr 2011 (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.
To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole/IUI | Experimental | Drug: Letrozole/IUIPatients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment. |
| CC/IUI | Active comparator | Drug: CC/IUIPatients received 100 mg CC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment. |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure
- No other infertility factors.
- Normal serum basal hormone levels as well as documented ovulation
Key exclusion criteria (4 listed)
- Moderate or severe endometriosis
- Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery
- Age more than 36 years, BMI more than 30 kg/m2
- women with a previous pregnancy
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 |
|---|---|---|
| Letrozole/IUIPatients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment. | Drug | Letrozole/IUI |
| CC/IUIPatients received 100 mg lCC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment. | Drug | CC/IUI |
Primary outcome
Clinical pregnancy rate per cycle
Time frame: 6-7 weeks gestation
1 secondary outcome
Miscarriage rate.
Time frame: Up to 20 weeks gestation
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 13 Apr 2011.
- Background: PubMed 12372451Dmowski WP, Pry M, Ding J, Rana N. Cycle-specific and cumulative fecundity in patients with endometriosis who are undergoing controlled ovarian hyperstimulation-intrauterine insemination or in vitro fertilization-embryo transfer. Fertil Steril. 2002 Oct;78(4):750-6. doi: 10.1016/s0015-0282(02)03343-5.
- Background: PubMed 16952506Werbrouck E, Spiessens C, Meuleman C, D'Hooghe T. No difference in cycle pregnancy rate and in cumulative live-birth rate between women with surgically treated minimal to mild endometriosis and women with unexplained infertility after controlled ovarian hyperstimulation and intrauterine insemination. Fertil Steril. 2006 Sep;86(3):566-71. doi: 10.1016/j.fertnstert.2006.01.044.
- Derived from this study: PubMed 22181973Abu Hashim H, El Rakhawy M, Abd Elaal I. Randomized comparison of superovulation with letrozole vs. clomiphene citrate in an IUI program for women with recently surgically treated minimal to mild endometriosis. Acta Obstet Gynecol Scand. 2012 Mar;91(3):338-45. doi: 10.1111/j.1600-0412.2011.01346.x. Epub 2012 Jan 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.
Hatem Abu Hashim, MD MRCOG principal investigator
Mansoura University Hospital
Mohamed El Rakhawy, MD study chair
Mansoura University Hospital
Ibrahim Abd Elaal study director
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole/IUI and CC/IUI in people with Endometriosis, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 4 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 13 Apr 2011. 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 Egypt. 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?
Clinical pregnancy rate per cycle (time frame: 6-7 weeks gestation). 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 NCT01334762, 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 13 Apr 2011.