EndometriosisNCT06577974
Role of Medical Treatment in Endometriosis Patients Undergoing ICSI
A study testing Combined contraceptive pills (Yasmin) in people with Endometriosis, run by Cairo University at 2 sites in Egypt.
Trial summary
The aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Combined contraceptive pills (Yasmin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2024to 1 Mar 2025
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of Endometrioma on ultrasound.
- History of ovarian cystectomy either open or via laparoscopic surgery.
- Presence of endometriotic foci in the pelvis during laparoscopic surgery.
- Patients coming for the first ICSI / IVF cycle.
Who cannot join
- Age above 40 years
- Cases with endometrioma on ultrasound more than 3 cm size.
- Prior failed ICSI / IVF.
- Known poor responders or poor ovarian reserve, defined as AFC<5 or AMH < 0.5 .
- Patients with previous uterine surgery.
- Patients diagnosed to have uterine abnormalities
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
ART unit, Obstetrics and Gynecology Department, Cairo University
Cairo
Mariam Dawoud, MD
- Recruiting
Cairo University/Obstetrics and Gynecology Department/ART Unit
Cairo
Mariam Dawoud, A. Professor, 00201157355666, zdawoud9@gmail.com
About this study
Official title: Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy
The aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility.
Read the detailed description
Patients complaining of infertility due to endometriosis diagnosed by ultrasound or laparoscopic surgery will be randomly allocated to three groups :
Group A: will receive COCPs for 3-6 months prior to starting IVF / ICSI cycle. Group B: will receive Dienogest for 3-6 months prior to starting IVF / ICSI cycle.
Group C: will be subjected to direct ICSI /IVF cycle. Then all patients will be subjected to ovarian stimulation regimen using GnRH Agonist Down-Regulation Gonadotropin Stimulation-The "Long" Protocol.
During the ovarian stimulation, the woman's response is monitored with serum estradiol levels and vaginal ultrasound examinations. The estradiol level is used to determine the dose of gonadotropins and whether under- or overstimulation occurs. The goal of the ovarian hyperstimulation is to develop at least three mature follicles that are 17 mm in diameter or larger. Once this is achieved, FSH and other medications are discontinued, and a single injection of hcg is given to mature the eggs to allow fertilization.
The hcg administration will also cause ovulation, but this does not occur until 40 hours or later after the injection. Therefore, it is standard that the hcg injection is administered 36 hours before the scheduled egg retrieval such that this will allow adequate maturation of the eggs and yet there would be little risk of ovulation.
Then the process will be continued through oocyte retrieval, oocyte maturation , fertilization by ICSI.
Each group will be followed up to detect the number of oocyte yield, fertilization rate and availability of good quality embryos and then according to the results the effect of medical treatment prior to stimulation will be assessed.
- Conditions
- Endometriosis
- Being tested
- Combined contraceptive pills (Yasmin)
- Keywords
- Oocyte yield, fertilisation rate
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined contraceptive pills (Yasmin)Drug
Also called Dienogest (Visanne)
medical pretreatment prior to ICSI
| Study group | Role | What they receive |
|---|---|---|
| Those treated by COCPs before IVSI | Experimental | Those with endometrisosis who will undergo ICSI after pretreatment with COCPs Receives: Drug: Combined contraceptive pills (Yasmin) |
| Those treated by Dionogest before ICSI | Experimental | Patients diagnosed with endometriosis who will undergo ICSI after oreteatment by dienogest Receives: Drug: Combined contraceptive pills (Yasmin) |
| Those undergoing ICSI straighaway | No intervention | patients diagnosed with endometriosis who will undergo ICSI without any medical pretretament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilisation rate
Number of embryos
Measured: 2 weeks from starting induction
Secondary outcomes (1)
clinical pregnancy rate
appearance of intrauterine gestational sac
Measured: 2 weeks from embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Jul 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ahmed Mohamed Dawoud, Cairo University
- Investigators
- Ahmed Taha, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577974
- Sponsor's protocol ID
- MD-70-2023
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, excel sheet
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy
- ClinicalTrials.gov ID
- NCT06577974
- Acronym / sponsor ID
- MD-70-2023
- Conditions
- Endometriosis
- Keywords
- Oocyte yield, fertilisation rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- 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 aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility.
Detailed description
Patients complaining of infertility due to endometriosis diagnosed by ultrasound or laparoscopic surgery will be randomly allocated to three groups :
Group A: will receive COCPs for 3-6 months prior to starting IVF / ICSI cycle. Group B: will receive Dienogest for 3-6 months prior to starting IVF / ICSI cycle.
Group C: will be subjected to direct ICSI /IVF cycle. Then all patients will be subjected to ovarian stimulation regimen using GnRH Agonist Down-Regulation Gonadotropin Stimulation-The "Long" Protocol.
During the ovarian stimulation, the woman's response is monitored with serum estradiol levels and vaginal ultrasound examinations. The estradiol level is used to determine the dose of gonadotropins and whether under- or overstimulation occurs. The goal of the ovarian hyperstimulation is to develop at least three mature follicles that are 17 mm in diameter or larger. Once this is achieved, FSH and other medications are discontinued, and a single injection of hcg is given to mature the eggs to allow fertilization.
The hcg administration will also cause ovulation, but this does not occur until 40 hours or later after the injection. Therefore, it is standard that the hcg injection is administered 36 hours before the scheduled egg retrieval such that this will allow adequate maturation of the eggs and yet there would be little risk of ovulation.
Then the process will be continued through oocyte retrieval, oocyte maturation , fertilization by ICSI.
Each group will be followed up to detect the number of oocyte yield, fertilization rate and availability of good quality embryos and then according to the results the effect of medical treatment prior to stimulation will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Those treated by COCPs before IVSI | Experimental | Drug: Combined contraceptive pills (Yasmin)Those with endometrisosis who will undergo ICSI after pretreatment with COCPs |
| Those treated by Dionogest before ICSI | Experimental | Drug: Combined contraceptive pills (Yasmin)Patients diagnosed with endometriosis who will undergo ICSI after oreteatment by dienogest |
| Those undergoing ICSI straighaway | No intervention | –patients diagnosed with endometriosis who will undergo ICSI without any medical pretretament |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of Endometrioma on ultrasound.
- History of ovarian cystectomy either open or via laparoscopic surgery.
- Presence of endometriotic foci in the pelvis during laparoscopic surgery.
- Patients coming for the first ICSI / IVF cycle.
Key exclusion criteria (6 listed)
- Age above 40 years
- Cases with endometrioma on ultrasound more than 3 cm size.
- Prior failed ICSI / IVF.
- Known poor responders or poor ovarian reserve, defined as AFC<5 or AMH < 0.5 .
- Patients with previous uterine surgery.
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 |
|---|---|---|
| Combined contraceptive pills (Yasmin)Also: Dienogest (Visanne)medical pretreatment prior to ICSI | Drug | Those treated by COCPs before IVSI, Those treated by Dionogest before ICSI |
Primary outcome
Fertilisation rate
Time frame: 2 weeks from starting induction
Number of embryos
1 secondary outcome
clinical pregnancy rate
Time frame: 2 weeks from embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No. Study protocol, excel sheet
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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.
Ahmed Taha, Professor study chair
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined contraceptive pills (Yasmin) in people with Endometriosis, run by Cairo University at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Dawoud, A. Professor (01157355666, zdawoud9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilisation rate (time frame: 2 weeks from starting induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2024.