ICSPhase 2NCT07318974
Melatonin Therapy for Improving ICSI Outcomes in Women With Diminished Ovarian Reserve
A Phase 2 study testing Melatonin capsule in people with ICS, run by Benha University at 1 site in Egypt.
Trial summary
Diminished ovarian reserve (DOR) is a major challenge in female fertility, often leading to poor oocyte quality and low pregnancy rates during assisted reproduction. Melatonin is a potent antioxidant that may protect developing eggs from oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ICS
- What is being tested?
- Melatonin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2025to Mar 2026
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Confirmed Diminished Ovarian Reserve (DOR) based on Bologna criteria (e.g., low AMH, low AFC).
- Undergoing ICSI with frozen blastocyst transfer (FBT) protocol.
- Willingness to comply with a 28-day pre-retrieval medication regimen.
Who cannot join
- Severe endometriosis or hydrosalpinx.
- Uterine anomalies (e.g., large fibroids or uterine septums).
- Chronic systemic diseases (e.g., uncontrolled diabetes or hypertension).
- Partner with severe male factor infertility requiring TESE/PESA (to isolate the effect on oocyte quality).
- Current use of other antioxidant supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Assessment of the Impact of Melatonin Therapy for Women With Diminished Ovarian Reserve on the Ovarian Reserve and the ICSI Outcomes
Diminished ovarian reserve (DOR) is a major challenge in female fertility, often leading to poor oocyte quality and low pregnancy rates during assisted reproduction. Melatonin is a potent antioxidant that may protect developing eggs from oxidative stress. This randomized clinical trial aims to evaluate whether a 4-week course of oral melatonin therapy before egg retrieval can improve the quality of oocytes and embryos, and ultimately increase pregnancy rates for women with DOR undergoing Intracytoplasmic Sperm Injection (ICSI). The study compares melatonin therapy against a placebo to assess its impact on follicular fluid health and clinical pregnancy success.
- Conditions
- ICS
- Being tested
- Melatonin capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin capsuleDrug
Participants receive 3mg of Melatonin Capsules
Dosage \& Frequency: Once at night
Duration: The treatment continues for 28 days
PlaceboDrug
Participants receive identical-appearing placebo capsule
Dosage \& Frequency: Once at night
Duration: The treatment continues for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Group | Active comparator | Participants receive one 3 mg Melatonin capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI. Receives: Drug: Melatonin capsule |
| Placebo Group | Active comparator | Participants receive an identical-appearing placebo capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered melatonin therapy.
Measured: 2-3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start10 Sep 2025
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICSStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318974
- Sponsor's protocol ID
- Rc 2.8.2025
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Assessment of the Impact of Melatonin Therapy for Women With Diminished Ovarian Reserve on the Ovarian Reserve and the ICSI Outcomes
- ClinicalTrials.gov ID
- NCT07318974
- Acronym / sponsor ID
- Rc 2.8.2025
- Conditions
- ICS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 Jan 2026 (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.
Diminished ovarian reserve (DOR) is a major challenge in female fertility, often leading to poor oocyte quality and low pregnancy rates during assisted reproduction. Melatonin is a potent antioxidant that may protect developing eggs from oxidative stress. This randomized clinical trial aims to evaluate whether a 4-week course of oral melatonin therapy before egg retrieval can improve the quality of oocytes and embryos, and ultimately increase pregnancy rates for women with DOR undergoing Intracytoplasmic Sperm Injection (ICSI). The study compares melatonin therapy against a placebo to assess its impact on follicular fluid health and clinical pregnancy success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin Group | Active comparator | Drug: Melatonin capsuleParticipants receive one 3 mg Melatonin capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI. |
| Placebo Group | Active comparator | Drug: PlaceboParticipants receive an identical-appearing placebo capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Confirmed Diminished Ovarian Reserve (DOR) based on Bologna criteria (e.g., low AMH, low AFC).
- Undergoing ICSI with frozen blastocyst transfer (FBT) protocol.
- Willingness to comply with a 28-day pre-retrieval medication regimen.
Key exclusion criteria (5 listed)
- Severe endometriosis or hydrosalpinx.
- Uterine anomalies (e.g., large fibroids or uterine septums).
- Chronic systemic diseases (e.g., uncontrolled diabetes or hypertension).
- Partner with severe male factor infertility requiring TESE/PESA (to isolate the effect on oocyte quality).
- Current use of other antioxidant supplements.
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 |
|---|---|---|
| Melatonin capsuleParticipants receive 3mg of Melatonin Capsules Dosage \& Frequency: Once at night Duration: The treatment continues for 28 days | Drug | Melatonin Group |
| PlaceboParticipants receive identical-appearing placebo capsule Dosage \& Frequency: Once at night Duration: The treatment continues for 28 days | Drug | Placebo Group |
Primary outcome
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
Time frame: 2-3 Months
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered melatonin therapy.
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 6 Jan 2026.
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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 2 study testing Melatonin capsule in people with ICS, run by Benha University 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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 Success Rate of Treatment Regimens in Achieving Clinical Pregnancy (time frame: 2-3 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 6 Jan 2026.