EndometriosisNCT03142035
Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF
A study testing Dienogest 2 MG, gonapeptyl and IVF/IVF+ART in people with Endometriosis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the reproductive age group . It is characterized by the presence of endometrial tissue outside the uterus, causing pelvic pain and subfertility. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Dienogest 2 MG, gonapeptyl and IVF/IVF+ART
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteLebanon
- Study dates
- 22 Oct 2017to 22 Feb 2023
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary or secondary infertility
- Endometriosis, stage III - IV, confirmed surgically by laparoscopy or laparotomy and/or radiologically by the presence of endometrioma on pelvic ultrasound or magnetic resonance imaging (MRI)
- Normal uterine cavity assessed by hysteroscopy or hysterosalpingogram
- Normal hormonal profile: TSH, prolactin, fasting blood sugar
- Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5 million/ml and/or normal WHO morphology >20%)
- First IVF cycle or history of failed IVF cycles
- Washout period of ≥6 months after any diagnostic or therapeutic surgery for endometriosis or after any medical treatment with Dienogest or GnRH agonist.
Who cannot join
- • Low ovarian reserve defined by one of the following: low AMH ≤1.5ng/mL and/or basal day 3 FSH ≥ 10mIU/mL and/or basal day 3 Estradiol ≥ 60ng/mL and/or previous egg collection yield of ≤3 oocytes.
- Absolute contraindications to dienogest, including:
- undiagnosed abnormal vaginal bleeding
- pregnancy and/or lactation
- active venous thromboembolic disorder
- history of or current arterial and cardiovascular disease (eg, MI, CVA)
Show all 13Show fewer
- diabetes mellitus with vascular involvement
- history of or current severe hepatic disease where liver function tests remain abnormal
- history of or current hepatic neoplasia (benign or malignant)
- known or suspected sex-hormone-dependent malignancy
- ocular lesions due to ophthalmic vascular disease, such as partial or complete vision loss or defect in visual fields
- current or history of migraine with focal aura
- hypersensitivity or poor tolerance to dienogest
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical center
Beirut
Dina Chamsi, 961-1350000 ext. 5612, dc09@aub.edu.lb
About this study
Official title: Dienogest Versus Gonadotropin Releasing Hormone Agonist Pre-treatment in Women With Endometriosis Undergoing in Vitro Fertilization
Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the reproductive age group . It is characterized by the presence of endometrial tissue outside the uterus, causing pelvic pain and subfertility. It is estimated that around 40% of infertile women have the diagnosis of endometriosis . Infertility secondary to endometriosis is thought to be multifactorial. Women with endometriosis often require in vitro fertilization (IVF). One medical intervention that has been shown to improve IVF outcomes in women with endometriosis is hormonal suppression with gonadotropic releasing hormone agonist (GnRH-a) for a period of 3 to 6 months .
In recent years, the effectiveness of dienogest, a fourth-generation progestin, for endometriosis treatment has been demonstrated. Dienogest seems to be as effective as GnRH-a in improving endometriosis-related pelvic pain [4]. However, no study has yet assessed whether dienogest has any benefit in treating endometriosis associated infertility.
The aim of our study is to evaluate the efficacy of dienogest versus GnRH-a in improving ongoing pregnancy rates in women undergoing IVF due to endometriosis. We will conduct a non-blinded randomized controlled trial. One group will receive dienogest 2mg daily for a period of 3 months followed by a standard IVF/Intracytoplasmic Sperm Injection (ICSI) cycle. The second group will receive one injection of 3.75mg of GnRH-a every 28 days for three doses followed by a standard IVF/ICSI cycle 3 months later. The third group will not receive any medical interventions before the planned IVF/ICSI cycle. We hypothesize that patients receiving dienogest will have similar ongoing pregnancy rates compared to patients receiving the GnRH-a injection. Secondary outcomes including number of gonadotropins consumed, number of stimulation days, number of metaphase II eggs retrieved, fertilization rate, embryo quality, miscarriage rate, clinical pregnancy rates, live birth rates and potential maternal and obstetrical complications will also be evaluated. We will also compare ongoing pregnancy rates between the groups receiving Dienogest and placebo, and GnRH agonist and placebo.
- Conditions
- Endometriosis
- Being tested
- Dienogest 2 MG, gonapeptyl, IVF/IVF+ART
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest 2 MGDrug
Dienogest is a fourth-generation progestin of 19-nortestosterone derivative, that has been shown to improve endometriosis associated pelvic pain. It is well tolerated with no androgenic, glucocorticoid or mineralocorticoid activity. Dienogest creates a hyperprogestogenic and hypoestrogenic environment that initially induces a secretory state and then a decidualization of the ectopic endometrium and finally its atrophy. It also inhibits aromatase and COX-2 expression as well as prostaglandin E2 production in endometriotic stromal cells. It also normalizes the activity of natural killer cells and decreases the release of interleukin-1b by macrophages. These anti-inflammatory properties further help in reducing the size of endometriotic lesions
gonapeptylDrug
gonadotropic releasing hormone agonist
IVF/IVF+ARTProcedure or surgery
In-vitro fertilization +/- assisted reproductive technology
| Study group | Role | What they receive |
|---|---|---|
| Dienogest | Experimental | patients will receive daily dienogest (2mg) for a total of 3 months (84 days) Receives: Drug: Dienogest 2 MG; Procedure: IVF/IVF+ART |
| GnRH agonist | Active comparator | patients will receive a single GnRH-a injection (3.25mg) every 28 days for three months. Receives: Drug: gonapeptyl; Procedure: IVF/IVF+ART |
| Control Group | Other | patients will not receive any medical intervention and will proceed with their IFV/ICSI cycles. Receives: Procedure: IVF/IVF+ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
pregnancy positive fetal cardiac activity with beyond 12 weeks of gestation (%)
Measured: 12 weeks of gestation
Secondary outcomes (7)
Gonadotropin consumption (IU)
Gonadotropin consumption (IU)
Measured: 3 months
stimulation (days)
Duration of stimulation (days)
Measured: up to 15 days
metaphase II oocytes retrieved
Number of metaphase II oocytes retrieved at the time of egg collection (n).
Measured: 12 weeks of gestation
Fertilization rate
the number of 2PN zygotes divided by the total number of mature metaphase II oocytes retrieved (%).
Measured: day 2
Embryo quality.
Embryo quality according to embryo grading at day 3 or day5
Measured: day 3 or 5
Clinical pregnancy rate
the presence of a gestational sac, with or without cardiac activity, on ultrasound assessment (%).
Measured: 12 weeks of gestation
Ongoing pregnancy rate -2
pregnancy positive fetal cardiac activity with beyond 12 weeks of gestation (%)
Measured: 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start22 Oct 2017
- Primary completion22 Feb 2023 (estimated)
- Study completion22 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Chamsy, American University of Beirut Medical Center
- Investigators
- Dina Chamsi, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142035
- Sponsor's protocol ID
- OGY.DC.03
- Status last verified
- May 2022
- First submitted
- 22 Feb 2017
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
PubMed 15541453Strathy JH, Molgaard CA, Coulam CB, Melton LJ 3rd. Endometriosis and infertility: a laparoscopic study of endometriosis among fertile and infertile women. Fertil Steril. 1982 Dec;38(6):667-72. doi: 10.1016/s0015-0282(16)46691-4.
PubMed 6216124Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2.
PubMed 16437491Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod. 2010 Mar;25(3):633-41. doi: 10.1093/humrep/dep469. Epub 2010 Jan 19.
PubMed 20089522Barnhart K, Dunsmoor-Su R, Coutifaris C. Effect of endometriosis on in vitro fertilization. Fertil Steril. 2002 Jun;77(6):1148-55. doi: 10.1016/s0015-0282(02)03112-6.
PubMed 12057720Matson PL, Yovich JL. The treatment of infertility associated with endometriosis by in vitro fertilization. Fertil Steril. 1986 Sep;46(3):432-4. doi: 10.1016/s0015-0282(16)49581-6.
PubMed 3091408Simon C, Gutierrez A, Vidal A, de los Santos MJ, Tarin JJ, Remohi J, Pellicer A. Outcome of patients with endometriosis in assisted reproduction: results from in-vitro fertilization and oocyte donation. Hum Reprod. 1994 Apr;9(4):725-9. doi: 10.1093/oxfordjournals.humrep.a138578.
PubMed 8046030Cahill DJ, Wardle PG, Maile LA, Harlow CR, Hull MG. Ovarian dysfunction in endometriosis-associated and unexplained infertility. J Assist Reprod Genet. 1997 Nov;14(10):554-7. doi: 10.1023/a:1022568331845.
PubMed 9447453Norenstedt SN, Linderoth-Nagy C, Bergendal A, Sjoblom P, Bergqvist A. Reduced developmental potential in oocytes from women with endometriosis. J Assist Reprod Genet. 2001 Dec;18(12):644-9. doi: 10.1023/a:1013111200251.
PubMed 11808845Nakahara K, Saito H, Saito T, Ito M, Ohta N, Takahashi T, Hiroi M. Ovarian fecundity in patients with endometriosis can be estimated by the incidence of apoptotic bodies. Fertil Steril. 1998 May;69(5):931-5. doi: 10.1016/s0015-0282(98)00038-7.
PubMed 9591505Pellicer A, Albert C, Mercader A, Bonilla-Musoles F, Remohi J, Simon C. The follicular and endocrine environment in women with endometriosis: local and systemic cytokine production. Fertil Steril. 1998 Sep;70(3):425-31. doi: 10.1016/s0015-0282(98)00204-0.
PubMed 9757870Toya M, Saito H, Ohta N, Saito T, Kaneko T, Hiroi M. Moderate and severe endometriosis is associated with alterations in the cell cycle of granulosa cells in patients undergoing in vitro fertilization and embryo transfer. Fertil Steril. 2000 Feb;73(2):344-50. doi: 10.1016/s0015-0282(99)00507-5.
PubMed 10685541Garcia-Velasco JA, Mulayim N, Kayisli UA, Arici A. Elevated soluble Fas ligand levels may suggest a role for apoptosis in women with endometriosis. Fertil Steril. 2002 Oct;78(4):855-9. doi: 10.1016/s0015-0282(02)03320-4.
PubMed 12372468Vercellini P, Somigliana E, Vigano P, Abbiati A, Barbara G, Crosignani PG. Surgery for endometriosis-associated infertility: a pragmatic approach. Hum Reprod. 2009 Feb;24(2):254-69. doi: 10.1093/humrep/den379. Epub 2008 Oct 23.
PubMed 18948311Geber S, Ferreira DP, Spyer Prates LF, Sales L, Sampaio M. Effects of previous ovarian surgery for endometriosis on the outcome of assisted reproduction treatment. Reprod Biomed Online. 2002 Sep-Oct;5(2):162-6. doi: 10.1016/s1472-6483(10)61619-7.
PubMed 12419041
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dienogest Versus Gonadotropin Releasing Hormone Agonist Pre-treatment in Women With Endometriosis Undergoing in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT03142035
- Acronym / sponsor ID
- OGY.DC.03
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- 22 Feb 2023 (estimated)
- Study completion
- 22 Feb 2023 (estimated)
- First posted
- 5 May 2017 (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.
Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the reproductive age group . It is characterized by the presence of endometrial tissue outside the uterus, causing pelvic pain and subfertility. It is estimated that around 40% of infertile women have the diagnosis of endometriosis . Infertility secondary to endometriosis is thought to be multifactorial. Women with endometriosis often require in vitro fertilization (IVF). One medical intervention that has been shown to improve IVF outcomes in women with endometriosis is hormonal suppression with gonadotropic releasing hormone agonist (GnRH-a) for a period of 3 to 6 months .
In recent years, the effectiveness of dienogest, a fourth-generation progestin, for endometriosis treatment has been demonstrated. Dienogest seems to be as effective as GnRH-a in improving endometriosis-related pelvic pain [4]. However, no study has yet assessed whether dienogest has any benefit in treating endometriosis associated infertility.
The aim of our study is to evaluate the efficacy of dienogest versus GnRH-a in improving ongoing pregnancy rates in women undergoing IVF due to endometriosis. We will conduct a non-blinded randomized controlled trial. One group will receive dienogest 2mg daily for a period of 3 months followed by a standard IVF/Intracytoplasmic Sperm Injection (ICSI) cycle. The second group will receive one injection of 3.75mg of GnRH-a every 28 days for three doses followed by a standard IVF/ICSI cycle 3 months later. The third group will not receive any medical interventions before the planned IVF/ICSI cycle. We hypothesize that patients receiving dienogest will have similar ongoing pregnancy rates compared to patients receiving the GnRH-a injection. Secondary outcomes including number of gonadotropins consumed, number of stimulation days, number of metaphase II eggs retrieved, fertilization rate, embryo quality, miscarriage rate, clinical pregnancy rates, live birth rates and potential maternal and obstetrical complications will also be evaluated. We will also compare ongoing pregnancy rates between the groups receiving Dienogest and placebo, and GnRH agonist and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dienogest | Experimental | Drug: Dienogest 2 MG, Procedure: IVF/IVF+ARTpatients will receive daily dienogest (2mg) for a total of 3 months (84 days) |
| GnRH agonist | Active comparator | Drug: gonapeptyl, Procedure: IVF/IVF+ARTpatients will receive a single GnRH-a injection (3.25mg) every 28 days for three months. |
| Control Group | Other | Procedure: IVF/IVF+ARTpatients will not receive any medical intervention and will proceed with their IFV/ICSI cycles. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Primary or secondary infertility
- Endometriosis, stage III - IV, confirmed surgically by laparoscopy or laparotomy and/or radiologically by the presence of endometrioma on pelvic ultrasound or magnetic resonance imaging (MRI)
- Normal uterine cavity assessed by hysteroscopy or hysterosalpingogram
- Normal hormonal profile: TSH, prolactin, fasting blood sugar
- Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5 million/ml and/or normal WHO morphology >20%)
Key exclusion criteria (13 listed)
- • Low ovarian reserve defined by one of the following: low AMH ≤1.5ng/mL and/or basal day 3 FSH ≥ 10mIU/mL and/or basal day 3 Estradiol ≥ 60ng/mL and/or previous egg collection yield of ≤3 oocytes.
- undiagnosed abnormal vaginal bleeding
- pregnancy and/or lactation
- active venous thromboembolic disorder
- history of or current arterial and cardiovascular disease (eg, MI, CVA)
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 |
|---|---|---|
| Dienogest 2 MGDienogest is a fourth-generation progestin of 19-nortestosterone derivative, that has been shown to improve endometriosis associated pelvic pain. It is well tolerated with no androgenic, glucocorticoid or mineralocorticoid activity. Dienogest creates a hyperprogestogenic and hypoestrogenic environment that initially induces a secretory state and then a decidualization of the ectopic endometrium and finally its atrophy. It also inhibits aromatase and COX-2 expression as well as prostaglandin E2 production in endometriotic stromal cells. It also normalizes the activity of natural killer cells and decreases the release of interleukin-1b by macrophages. These anti-inflammatory properties further help in reducing the size of endometriotic lesions | Drug | Dienogest |
| gonapeptylgonadotropic releasing hormone agonist | Drug | GnRH agonist |
| IVF/IVF+ARTIn-vitro fertilization +/- assisted reproductive technology | Procedure or surgery | Control Group, Dienogest, GnRH agonist |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks of gestation
pregnancy positive fetal cardiac activity with beyond 12 weeks of gestation (%)
7 secondary outcomes
Gonadotropin consumption (IU)
Time frame: 3 months
stimulation (days)
Time frame: up to 15 days
metaphase II oocytes retrieved
Time frame: 12 weeks of gestation
Fertilization rate
Time frame: day 2
Embryo quality.
Time frame: day 3 or 5
Clinical pregnancy rate
Time frame: 12 weeks of gestation
Ongoing pregnancy rate -2
Time frame: 12 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 15541453Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
- Background: PubMed 6216124Strathy JH, Molgaard CA, Coulam CB, Melton LJ 3rd. Endometriosis and infertility: a laparoscopic study of endometriosis among fertile and infertile women. Fertil Steril. 1982 Dec;38(6):667-72. doi: 10.1016/s0015-0282(16)46691-4.
- Background: PubMed 16437491Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2.
- Background: PubMed 20089522Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod. 2010 Mar;25(3):633-41. doi: 10.1093/humrep/dep469. Epub 2010 Jan 19.
- Background: PubMed 12057720Barnhart K, Dunsmoor-Su R, Coutifaris C. Effect of endometriosis on in vitro fertilization. Fertil Steril. 2002 Jun;77(6):1148-55. doi: 10.1016/s0015-0282(02)03112-6.
- Background: PubMed 3091408Matson PL, Yovich JL. The treatment of infertility associated with endometriosis by in vitro fertilization. Fertil Steril. 1986 Sep;46(3):432-4. doi: 10.1016/s0015-0282(16)49581-6.
- Background: PubMed 8046030Simon C, Gutierrez A, Vidal A, de los Santos MJ, Tarin JJ, Remohi J, Pellicer A. Outcome of patients with endometriosis in assisted reproduction: results from in-vitro fertilization and oocyte donation. Hum Reprod. 1994 Apr;9(4):725-9. doi: 10.1093/oxfordjournals.humrep.a138578.
- Background: PubMed 9447453Cahill DJ, Wardle PG, Maile LA, Harlow CR, Hull MG. Ovarian dysfunction in endometriosis-associated and unexplained infertility. J Assist Reprod Genet. 1997 Nov;14(10):554-7. doi: 10.1023/a:1022568331845.
- Background: PubMed 11808845Norenstedt SN, Linderoth-Nagy C, Bergendal A, Sjoblom P, Bergqvist A. Reduced developmental potential in oocytes from women with endometriosis. J Assist Reprod Genet. 2001 Dec;18(12):644-9. doi: 10.1023/a:1013111200251.
- Background: PubMed 9591505Nakahara K, Saito H, Saito T, Ito M, Ohta N, Takahashi T, Hiroi M. Ovarian fecundity in patients with endometriosis can be estimated by the incidence of apoptotic bodies. Fertil Steril. 1998 May;69(5):931-5. doi: 10.1016/s0015-0282(98)00038-7.
- Background: PubMed 9757870Pellicer A, Albert C, Mercader A, Bonilla-Musoles F, Remohi J, Simon C. The follicular and endocrine environment in women with endometriosis: local and systemic cytokine production. Fertil Steril. 1998 Sep;70(3):425-31. doi: 10.1016/s0015-0282(98)00204-0.
- Background: PubMed 10685541Toya M, Saito H, Ohta N, Saito T, Kaneko T, Hiroi M. Moderate and severe endometriosis is associated with alterations in the cell cycle of granulosa cells in patients undergoing in vitro fertilization and embryo transfer. Fertil Steril. 2000 Feb;73(2):344-50. doi: 10.1016/s0015-0282(99)00507-5.
- Individual participant dataSharing planned: No
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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.
Dina Chamsi, MD principal investigator
American University of Beirut 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 Dienogest 2 MG, gonapeptyl and IVF/IVF+ART in people with Endometriosis, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 7 inclusion and 13 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 23 May 2022. 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 Lebanon. 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 Dina Chamsi, MD (961-01350000 ext. 5612, dc09@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks of 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 NCT03142035, which also lists 23 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 May 2022.