SterilityPhase 4NCT03619707
Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
A Phase 4 study testing Progesterone in people with Sterility and Infertility, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Sterility, Infertility
- What is being tested?
- Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Aug 2018to 1 Oct 2021
- Phase
- Phase 4
- 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
- Normal uterine cavity
- Normal Hormonal investigation: TSH,PRL,FBS
- Frozen embryo transfer cycles: at least 2 embryos
- Primary or secondary infertility: tubal occlusion, male factor, unexplained, endometriosis, ovarian factors…
- Body mass index (BMI) ≥18 to ≤30 kg/m2
Who cannot join
- Preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…)
- History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer
- History of three or more miscarriages
- Previous allergy reactions to progesterone products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Dydrogesterone Versus Vaginal Progesterone in the Luteal Phase Support in Cryo-warmed Embryo Transfer Cycles: Randomized Controlled Trial
In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established. Currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. However, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance.
Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone (MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were 37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively.
Read more
Regarding the administration route of progesterone, intramuscular and transvaginal routes are the two conventional progesterone administration techniques. However, very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles.
The objective of the investigator's study is to demonstrate the superiority of oral dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.
- Conditions
- Sterility, Infertility
- Being tested
- Progesterone
- Keywords
- Luteal Phase Support, Cryo-warmed Embryo Transfer, Assisted Reproductive Technology
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Patients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.
| Study group | Role | What they receive |
|---|---|---|
| Oral Dydrogesterone | Experimental | Oral dydrogesterone (Duphaston 10 mg) will be given orally four times daily : will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test. Receives: Drug: Progesterone |
| Vaginal microprogesterone | Experimental | Vaginal progesterone (Utrogestan 200 mg) will be given vaginally four times daily: will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live births per embryo transferred
Number of live births per number of embryos transferred
Measured: until date of delivery
Secondary outcomes (4)
Ongoing or Clinical pregnancy rate per started treatment cycle (CPR)
The presence of a viable fetus at 20 weeks gestation or fetal heart beat on transvaginal ultrasound after 6-7 weeks of gestation
Measured: 20 weeks from Last Menstrual Period (LMP)
Implantation rate (IR)
Number of intrauterine gestational sacs observed on transvaginal ultrasound divided by the number of transferred embryos
Measured: 7 weeks from LMP
Miscarriage rates
Pregnancy loss prior to 12 weeks of gestation
Measured: From a positive pregnancy test till 12 weeks gestation
Multiple gestation rate
More than one intra-uterine gestation sac at 6 weeks of gestation
Measured: 6-7 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 posted8 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Awwad, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619707
- Sponsor's protocol ID
- AmericanUBMC-CWET
- Status last verified
- Jul 2023
- First submitted
- 3 Aug 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dydrogesterone Versus Vaginal Progesterone in the Luteal Phase Support in Cryo-warmed Embryo Transfer Cycles: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03619707
- Acronym / sponsor ID
- AmericanUBMC-CWET
- Conditions
- Sterility, Infertility
- Keywords
- Luteal Phase Support, Cryo-warmed Embryo Transfer, Assisted Reproductive Technology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 8 Aug 2018 (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.
In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established. Currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. However, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance.
Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone (MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were 37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively.
Regarding the administration route of progesterone, intramuscular and transvaginal routes are the two conventional progesterone administration techniques. However, very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles.
The objective of the investigator's study is to demonstrate the superiority of oral dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Dydrogesterone | Experimental | Drug: ProgesteroneOral dydrogesterone (Duphaston 10 mg) will be given orally four times daily : will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test. |
| Vaginal microprogesterone | Experimental | Drug: ProgesteroneVaginal progesterone (Utrogestan 200 mg) will be given vaginally four times daily: will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Normal uterine cavity
- Normal Hormonal investigation: TSH,PRL,FBS
- Frozen embryo transfer cycles: at least 2 embryos
- Primary or secondary infertility: tubal occlusion, male factor, unexplained, endometriosis, ovarian factors…
- Body mass index (BMI) ≥18 to ≤30 kg/m2
Key exclusion criteria (4 listed)
- Preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…)
- History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer
- History of three or more miscarriages
- Previous allergy reactions to progesterone products
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 |
|---|---|---|
| ProgesteronePatients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone. | Drug | Oral Dydrogesterone, Vaginal microprogesterone |
Primary outcome
Live births per embryo transferred
Time frame: until date of delivery
Number of live births per number of embryos transferred
4 secondary outcomes
Ongoing or Clinical pregnancy rate per started treatment cycle (CPR)
Time frame: 20 weeks from Last Menstrual Period (LMP)
Implantation rate (IR)
Time frame: 7 weeks from LMP
Miscarriage rates
Time frame: From a positive pregnancy test till 12 weeks gestation
Multiple gestation rate
Time frame: 6-7 weeks of 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 20 Jul 2023.
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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 Phase 4 study testing Progesterone in people with Sterility and Infertility, 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 5 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 20 Jul 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Live births per embryo transferred (time frame: until date of delivery). 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 20 Jul 2023.