IVFNCT04500743
Role of Suppression of Endometriosis With Progestins Before IVF-ET
A study testing Dienogest and leuprorelin acetate in people with IVF and Endometriosis, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF, Endometriosis, Pregnancy Rate
- What is being tested?
- Dienogest and leuprorelin acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 30 Apr 2020
- 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 30 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- confirmed diagnosis of endometriosis
- body mass index < 35 Kg/m2
Who cannot join
- if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis
- liver or kidney disease
- evidence of diminished ovarian reserve (e.g. high FSH level >12 IU/L or low AMH level <1 ng/ml).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial
This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.
- Conditions
- IVF, Endometriosis, Pregnancy Rate, Progestins, GnRH-analogue
- Being tested
- Dienogest, leuprorelin acetate
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
leuprorelin acetateDrug
Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)
| Study group | Role | What they receive |
|---|---|---|
| Dienogest | Active comparator | Not described Receives: Drug: Dienogest |
| GnRH analogue | Active comparator | Not described Receives: Drug: leuprorelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of retrieved oocytes
the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness
Measured: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
Secondary outcomes (7)
the fertilization rate
defined as the number of zygotes with two pronuclei divided by the number of oocytes
Measured: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the number of transferrable embryos
defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation
Measured: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the cost of the treatment
the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs
Measured: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
pregnancy rate per cycle started
defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment
Measured: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the clinical pregnancy rate per cycle started
defined as the number of patients with at least one intrauterine gestational sac with identifiable fetal heart pulsations over the total number of patients starting the treatment
Measured: after women have postive pregnancy test (2 weeks after after the embryo transfer)
the miscarriage rate
defined as patients with identified intrauterine gestational sac without a fetal pole, or a fetal pole with no heart pulsations with no other viable fetuses over the number of patients with positive pregnancy test
Measured: After occurence of the clinical pregnancy (5 months after after the embryo transfer)
patient's quality of life
patient's quality of life during the pretreatment period as assessed by the Fertility quality of life (FertiQoL) questionnaire with a range of 0 (the worst) to 100 (the best).
Measured: throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Aug 2018
- Primary completion31 Oct 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IVFStudies 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazen Abdel Rasheed, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500743
- Sponsor's protocol ID
- Dienogest before IVF
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen I, Kives S, Zakhari A, Nguyen DB, Goldberg HR, Choudhry AJ, Le AL, Kowalczewski E, Schroll JB. Progestagens for pain symptoms associated with endometriosis. Cochrane Database Syst Rev. 2025 Oct 9;10(10):CD002122. doi: 10.1002/14651858.CD002122.pub3.
PubMed 41065045Khalifa E, Mohammad H, Abdullah A, Abdel-Rasheed M, Khairy M, Hosni M. Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2021 Mar 30;21(1):264. doi: 10.1186/s12884-021-03736-2.
PubMed 33784989
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04500743
- Acronym / sponsor ID
- Dienogest before IVF
- Conditions
- IVF, Endometriosis, Pregnancy Rate, Progestins, GnRH-analogue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Aug 2020 (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.
This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dienogest | Active comparator | Drug: Dienogest |
| GnRH analogue | Active comparator | Drug: leuprorelin acetate |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- confirmed diagnosis of endometriosis
- body mass index < 35 Kg/m2
Key exclusion criteria (3 listed)
- if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis
- liver or kidney disease
- evidence of diminished ovarian reserve (e.g. high FSH level >12 IU/L or low AMH level <1 ng/ml).
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 |
|---|---|---|
| DienogestGroup B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF | Drug | Dienogest |
| leuprorelin acetateGroup A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol) | Drug | GnRH analogue |
Primary outcome
the number of retrieved oocytes
Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness
7 secondary outcomes
the fertilization rate
Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the number of transferrable embryos
Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the cost of the treatment
Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
pregnancy rate per cycle started
Time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the clinical pregnancy rate per cycle started
Time frame: after women have postive pregnancy test (2 weeks after after the embryo transfer)
the miscarriage rate
Time frame: After occurence of the clinical pregnancy (5 months after after the embryo transfer)
patient's quality of life
Time frame: throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 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 5 Aug 2020.
- Derived from this study: PubMed 41065045Chen I, Kives S, Zakhari A, Nguyen DB, Goldberg HR, Choudhry AJ, Le AL, Kowalczewski E, Schroll JB. Progestagens for pain symptoms associated with endometriosis. Cochrane Database Syst Rev. 2025 Oct 9;10(10):CD002122. doi: 10.1002/14651858.CD002122.pub3.
- Derived from this study: PubMed 33784989Khalifa E, Mohammad H, Abdullah A, Abdel-Rasheed M, Khairy M, Hosni M. Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial. BMC Pregnancy Childbirth. 2021 Mar 30;21(1):264. doi: 10.1186/s12884-021-03736-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dienogest and leuprorelin acetate in people with IVF and Endometriosis, run by National Research Centre, Egypt 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 2 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 5 Aug 2020. 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?
the number of retrieved oocytes (time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)). 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 NCT04500743, which also lists 2 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 5 Aug 2020.