Low DoseNCT06928844
Role of Low Dose Injectable Progesterone in Triggering Ovulation
A study testing Progesterone in people with Low Dose and Progesterone, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Low Dose, Progesterone, Triggering Ovulation
- What is being tested?
- Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 35 years.
- Infertile women.
- Basal follicle-stimulating hormone (FSH) level <10 mIU/ml.
Who cannot join
- Poor ovarian reserve.
- Immunological disease.
- Endometriosis.
- Uterine abnormality.
- Body mass index (BMI) >30 kg/m2.
- Endometrial thickness <8 or >12 mm on the day of triggering.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Teaching Hospitals and Institutes
Cairo
Abeer A El Shabasi, MD, 00201223331182, abear.elshabacy@gmail.com
Mohamed A Raslan, MD
About this study
Official title: Role of Low Dose Injectable Progesterone in Triggering Ovulation: A Randomized Controlled Trial
The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation.
Read the detailed description
Infertility affects approximately 10-15% of couples attempting pregnancy, with no readily identifiable cause found in 15-30% of these patients, resulting in a diagnosis of unexplained infertility.
Kol and Itskovitz-Eldor stated that when using GnRH agonist to trigger ovulation in IVF cycles, the LH surge is associated with a rapid rise of progesterone and the attainment of peak E2 levels through the first 12 h after GnRH agonist administration which is followed by a temporary suppression of progesterone biosynthesis and a gradual drop in E2 levels during the 24 h before follicle aspiration. After oocyte retrieval, a second rise in progesterone and continuous fall in E2 are noted, reflecting transitions from follicular to luteal phase in ovarian steroidogenesis.
Letrozole (LE) is a nonsteroidal, highly selective oral aromatase inhibitor (AI) that inhibits the synthesis of oestrogen and increases the secretion of endogenous gonadotropin by diminishing negative feedback to stimulate ovulation. Currently, letrozole is widely used as an adjunct for IVF cycles.
- Conditions
- Low Dose, Progesterone, Triggering Ovulation
- Being tested
- Progesterone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Women will receive low dose progesterone 5 mg intramuscularly as a study group. (Letrozole 2.5 mg/day will be given from cycle day 3 onwards for only 5 days).
PlaceboDrug
Women will receive placebo as a control group. (Placebo 2.5 mg/day will be given from cycle day 3 onwards for only 5 days).
| Study group | Role | What they receive |
|---|---|---|
| Progesterone group | Experimental | Women will receive low dose progesterone 5 mg intramuscularly as a study group. Receives: Drug: Progesterone |
| Control group | Placebo comparator | Women will receive placebo as a control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ovulation rates
Incidence of ovulation rates will be recorded.
Measured: 10-12 days of the menstrual cycle
Secondary outcomes (9)
Follicle stimulating hormone (FSH)levels
Follicle stimulating hormone (FSH) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.
Measured: 10-12 days of the menstrual cycle
Luteinizing hormone (LH)levels
Luteinizing hormone (LH) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval).
Measured: 10-12 days of the menstrual cycle
Estradiol (E2) levels
Estradiol (E2) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.
Measured: 10-12 days of the menstrual cycle
Progesterone levels
Progesterone levels will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.
Measured: 10-12 days of the menstrual cycle
Number of oocytes
Number of oocytes will be recorded. Ovulation monitoring will be done from the last day of the cycle until ovulation occurs approximately in the middle of the cycle.
Measured: 8 days of the menstrual cycle
Mature oocytes
Mature oocytes will be recorded.
Measured: 16 days of the menstrual cycle
Clinical pregnancy rate.
Clinical pregnancy rate will be recorded.
Measured: One week late from the previous menstrual cycle
Biochemical pregnancy
Biochemical pregnancy will be recorded through a blood pregnancy test on the date of the next menstrual period
Measured: 16 days of the menstrual cycle
Early miscarriage rate
Early miscarriage rate will be recorded.
Measured: 16 days of the menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Apr 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low DoseStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Abeer Ali Elshabacy, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928844
- Sponsor's protocol ID
- 36264PR1017/12/24
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low Dose Injectable Progesterone in Triggering Ovulation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06928844
- Acronym / sponsor ID
- 36264PR1017/12/24
- Conditions
- Low Dose, Progesterone, Triggering Ovulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Apr 2025 (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 is to evaluate the role of low dose injectable progesterone in triggering ovulation.
Detailed description
Infertility affects approximately 10-15% of couples attempting pregnancy, with no readily identifiable cause found in 15-30% of these patients, resulting in a diagnosis of unexplained infertility.
Kol and Itskovitz-Eldor stated that when using GnRH agonist to trigger ovulation in IVF cycles, the LH surge is associated with a rapid rise of progesterone and the attainment of peak E2 levels through the first 12 h after GnRH agonist administration which is followed by a temporary suppression of progesterone biosynthesis and a gradual drop in E2 levels during the 24 h before follicle aspiration. After oocyte retrieval, a second rise in progesterone and continuous fall in E2 are noted, reflecting transitions from follicular to luteal phase in ovarian steroidogenesis.
Letrozole (LE) is a nonsteroidal, highly selective oral aromatase inhibitor (AI) that inhibits the synthesis of oestrogen and increases the secretion of endogenous gonadotropin by diminishing negative feedback to stimulate ovulation. Currently, letrozole is widely used as an adjunct for IVF cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone group | Experimental | Drug: ProgesteroneWomen will receive low dose progesterone 5 mg intramuscularly as a study group. |
| Control group | Placebo comparator | Drug: PlaceboWomen will receive placebo as a control group |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 20 to 35 years.
- Infertile women.
- Basal follicle-stimulating hormone (FSH) level <10 mIU/ml.
Key exclusion criteria (6 listed)
- Poor ovarian reserve.
- Immunological disease.
- Endometriosis.
- Uterine abnormality.
- Body mass index (BMI) >30 kg/m2.
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 |
|---|---|---|
| ProgesteroneWomen will receive low dose progesterone 5 mg intramuscularly as a study group. (Letrozole 2.5 mg/day will be given from cycle day 3 onwards for only 5 days). | Drug | Progesterone group |
| PlaceboWomen will receive placebo as a control group. (Placebo 2.5 mg/day will be given from cycle day 3 onwards for only 5 days). | Drug | Control group |
Primary outcome
Incidence of ovulation rates
Time frame: 10-12 days of the menstrual cycle
Incidence of ovulation rates will be recorded.
9 secondary outcomes
Follicle stimulating hormone (FSH)levels
Time frame: 10-12 days of the menstrual cycle
Luteinizing hormone (LH)levels
Time frame: 10-12 days of the menstrual cycle
Estradiol (E2) levels
Time frame: 10-12 days of the menstrual cycle
Progesterone levels
Time frame: 10-12 days of the menstrual cycle
Number of oocytes
Time frame: 8 days of the menstrual cycle
Mature oocytes
Time frame: 16 days of the menstrual cycle
Clinical pregnancy rate.
Time frame: One week late from the previous menstrual cycle
Biochemical pregnancy
Time frame: 16 days of the menstrual cycle
Early miscarriage rate
Time frame: 16 days of the menstrual cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progesterone in people with Low Dose and Progesterone, run by The General Authority for Teaching Hospitals and Institutes 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 3 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: looking for participants now, as of the sponsor's last update on 16 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer A El Shabasi, MD (00201223331182, abear.elshabacy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ovulation rates (time frame: 10-12 days of the menstrual cycle). 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 16 Apr 2025.