EndometriomaGnRhNCT02737800
Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients
A study testing endometrioma aspiration, GnRh agonist ( Decapeptyl ) and standard long stimulation protocol in people with Endometrioma, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Investigators compare ICSI results for endometrioma patients with or without cyst aspiration if more than 5cm \&with or without GnRh agonists for all endometrioma patients Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- endometrioma aspiration, GnRh agonist ( Decapeptyl ) and standard long stimulation protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Aug 2017
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- endometrioma patients
Who cannot join
- Follicle stimulating hormone(FSH)10 or more
- hydrosalpinx
- GnRh suppression in the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prolonged GnRh Agonist Therapy on the Outcome of In-Vitro Fertilization& Embryo Transfer in Endometrioma Patients
Investigators compare ICSI results for endometrioma patients with or without cyst aspiration if more than 5cm \&with or without GnRh agonists for all endometrioma patients
Read the detailed description
Group 1 consists of 30 patients of endometrioma more than 5cm subdivided into:
Group 1A;Cyst aspiration followed by standard long protocol in 15 patients Group 1B;Cyst aspiration followed by GnRh suppression for 3 months then standard long protocol in 15 patients
Group 2 consists of 30 patients of endometrioma less than 5cm subdivided into :
Group 2A;no intervention to the cyst. Standard long protocol Group 2B;GnRh suppression for 3 months then standard long protocol
- Conditions
- Endometrioma
- Being tested
- endometrioma aspiration, GnRh agonist ( Decapeptyl ), standard long stimulation protocol
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrioma aspirationProcedure or surgery
Transvaginal ultrasound guided aspiration
GnRh agonist ( Decapeptyl )Drug
Also called Decapeptyl
3 monthly doses of Decapeptyl 7.5mg intramuscular
standard long stimulation protocolProcedure or surgery
Decapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size \&serum estradiol.
| Study group | Role | What they receive |
|---|---|---|
| 1A endometrioma more than 5cm | Active comparator | Endometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI Receives: Procedure: endometrioma aspiration; Drug: GnRh agonist ( Decapeptyl ); Procedure: standard long stimulation protocol |
| 1B endometrioma more than 5cm control | Sham comparator | Endometrioma aspiration Standard long stimulation protocol \& ICSI Receives: Procedure: endometrioma aspiration; Procedure: standard long stimulation protocol |
| 2A endometrioma less than 5cm | Active comparator | Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI Receives: Drug: GnRh agonist ( Decapeptyl ); Procedure: standard long stimulation protocol |
| 2B endometrioma less than 5cm control | Sham comparator | Standard long stimulation protocol \& ICSI Receives: Procedure: standard long stimulation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with urine pregnancy test positive 2 weeks after embryo transfer
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suzy abdelaziz Abdelhamid, Kasr El Aini Hospital
- Investigators
- suzy abdelaziz, lecturer, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737800
- Sponsor's protocol ID
- obgynivf
- Acronym
- GnRh
- Status last verified
- Jul 2018
- First submitted
- 31 Mar 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged GnRh Agonist Therapy on the Outcome of In-Vitro Fertilization& Embryo Transfer in Endometrioma Patients
- ClinicalTrials.gov ID
- NCT02737800
- Acronym / sponsor ID
- GnRh / obgynivf
- Conditions
- Endometrioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Apr 2016 (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.
Investigators compare ICSI results for endometrioma patients with or without cyst aspiration if more than 5cm \&with or without GnRh agonists for all endometrioma patients
Detailed description
Group 1 consists of 30 patients of endometrioma more than 5cm subdivided into:
Group 1A;Cyst aspiration followed by standard long protocol in 15 patients Group 1B;Cyst aspiration followed by GnRh suppression for 3 months then standard long protocol in 15 patients
Group 2 consists of 30 patients of endometrioma less than 5cm subdivided into :
Group 2A;no intervention to the cyst. Standard long protocol Group 2B;GnRh suppression for 3 months then standard long protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1A endometrioma more than 5cm | Active comparator | Procedure: endometrioma aspiration, Drug: GnRh agonist ( Decapeptyl ), Procedure: standard long stimulation protocolEndometrioma aspiration GnRh agonist :Decapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI |
| 1B endometrioma more than 5cm control | Sham comparator | Procedure: endometrioma aspiration, Procedure: standard long stimulation protocolEndometrioma aspiration Standard long stimulation protocol \& ICSI |
| 2A endometrioma less than 5cm | Active comparator | Drug: GnRh agonist ( Decapeptyl ), Procedure: standard long stimulation protocolDecapeptyl 3.75mg intramuscular Standard long stimulation protocol \& ICSI |
| 2B endometrioma less than 5cm control | Sham comparator | Procedure: standard long stimulation protocolStandard long stimulation protocol \& ICSI |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- endometrioma patients
Key exclusion criteria (3 listed)
- Follicle stimulating hormone(FSH)10 or more
- hydrosalpinx
- GnRh suppression in the last 12 months
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 |
|---|---|---|
| endometrioma aspirationTransvaginal ultrasound guided aspiration | Procedure or surgery | 1A endometrioma more than 5cm, 1B endometrioma more than 5cm control |
| GnRh agonist ( Decapeptyl )Also: Decapeptyl3 monthly doses of Decapeptyl 7.5mg intramuscular | Drug | 1A endometrioma more than 5cm, 2A endometrioma less than 5cm |
| standard long stimulation protocolDecapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size \&serum estradiol. | Procedure or surgery | 1A endometrioma more than 5cm, 1B endometrioma more than 5cm control, 2A endometrioma less than 5cm, 2B endometrioma less than 5cm control |
Primary outcome
Number of patients with urine pregnancy test positive 2 weeks after embryo transfer
Time frame: 5 months
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 31 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Endometrioma
RecruitingPhase 4
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Ovarian Endometrioma, Endometrioma
Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Recruiting
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Endometriosis
RecruitingObservational study
Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
Endometriosis
Not yet recruitingObservational study
Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas
Endometriosis, Endometrioma
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.
suzy abdelaziz, lecturer principal investigator
Kasr El Aini 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 endometrioma aspiration, GnRh agonist ( Decapeptyl ) and standard long stimulation protocol in people with Endometrioma, run by Kasr El Aini Hospital 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 1 inclusion and 3 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 31 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
Number of patients with urine pregnancy test positive 2 weeks after embryo transfer (time frame: 5 months). 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 31 Jul 2018.