Progesterone Primed Endometrial ProtocolNCT06297564
Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments
A study testing Progesterone primed endometrial protocol and Gonadotropin-releasing hormone antagonist protocol in people with Progesterone Primed Endometrial Protocol and Gonadotropin Releasing Hormone Antagonist Protocol, run by New Valley University at 1 site in Egypt.
Trial summary
The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Progesterone Primed Endometrial Protocol, Gonadotropin Releasing Hormone Antagonist Protocol, Assisted Reproductive Treatments
- What is being tested?
- Progesterone primed endometrial protocol and Gonadotropin-releasing hormone antagonist protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jan 2024
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 to 40 years.
- A basal antral follicle count (AFC) <6.
- All patients had to have a body mass index between 18.5 to 29.9 kg/m2.
- Undergoing IVF/ICSI cycles.
- With previous poor response to conventional prolonged therapy utilizing GnRH agonists (retrieving three oocytes).
Who cannot join
- Cycles with fresh embryo transfer.
- Transfers of cleavage embryos (d2/d3).
- Embryos from cycles with preimplantation genetic screening.
- Cryopreservation of oocytes.
- Oocyte donation cycles.
- Cycles that produced embryos but without et at the time of the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Women Undergoing Assisted Reproductive Treatments
The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments.
Read the detailed description
Utilizing the assisted reproductive techniques (ART) has exhibited a substantial rise within the last years, emerging as a crucial modern medicine component with reliable results.
The utilized protocols for endometrial preparation in ART are aimed at maximizing the treatments' success. Typically, utilizing gonadotropin-stimulating hormone (GnRH) antagonists or agonists remains involved for preventing an early luteinizing hormone (LH) peak along ovulation prior to oocytes retrieval.
The GnRH-antagonist (GnRH-a) protocol is favored by many clinicians as well as patients due to its simplicity, convenience, flexibility, and absence of functional ovarian cysts or "menopausal" symptoms linked to the agonist protocol. Nevertheless, some RCTs' findings address that the antagonist protocol yields a reduced oocytes' number. Additionally, it exhibits lower pregnancy rates as opposed to the agonist extended therapy.
- Conditions
- Progesterone Primed Endometrial Protocol, Gonadotropin Releasing Hormone Antagonist Protocol, Assisted Reproductive Treatments
- Being tested
- Progesterone primed endometrial protocol, Gonadotropin-releasing hormone antagonist protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone primed endometrial protocolOther
The cases were received soft progesterone capsules (brand name: Utrogestan, 100 mg, Laboratories Besins International, France) 100 mg and 150 IU of human menopausal gonadotropin (hMG) concomitantly from the menstrual cycle (MC) day 3 until the trigger day.
Gonadotropin-releasing hormone antagonist protocolOther
The cases were received the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol consisting of HMG 150 IU's daily injection from MC 3 until the trigger day. GnRH-ant (Cetrotide, 0.25 mg, MerckSerono) was started when at least one of the following criteria were met: LH >10 IU/L, the presence of at least one follicle with mean diameter >14 mm, or serum E2 level >600 pg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone primed endometrial protocol | Active comparator | The cases were received soft progesterone capsules (brand name: Utrogestan, 100 mg, Laboratories Besins International, France) 100 mg and 150 IU of human menopausal gonadotropin (hMG) concomitantly from the menstrual cycle (MC) day 3 until the trigger day Receives: Other: Progesterone primed endometrial protocol |
| Gonadotropin-releasing hormone antagonist protocol | Experimental | The cases were received the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol consisting of HMG 150 IU's daily injection from MC 3 until the trigger day. GnRH-ant (Cetrotide, 0.25 mg, MerckSerono) was started when at least one of the following criteria were met: LH >10 IU/L, the presence of at least one follicle with mean diameter >14 mm, or serum E2 level >600 pg/mL. Receives: Other: Gonadotropin-releasing hormone antagonist protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of retrieved oocytes
Retrieved oocytes will be collected after ovarian induction by gonadotropin injection
Measured: 34 to 36 hours post HCG administration
Secondary outcomes (1)
Pregnancy rate
Biochemical pregnancy was determined as serum HCG higher than 25 mIU/ml at twelve to fourteen days following the transfer. Gynecological ultrasound assessment was accomplished at thirty to thirty-five following the transfer. Additionally, the gestational sac existence was regarded as clinical pregnancy, with the clinical pregnancy rate = (clinical pregnancy cycles' number/ all transfer cycles' number) × 100%. Moreover, live birth rate equals (live birth cycles' number/ all transfer cycles' number) × 100%
Measured: Fourteen days following the transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Sep 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progesterone Primed Endometrial ProtocolStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ahmad Ali, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297564
- Sponsor's protocol ID
- 07/3/9-2023/4
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Women Undergoing Assisted Reproductive Treatments
- ClinicalTrials.gov ID
- NCT06297564
- Acronym / sponsor ID
- 07/3/9-2023/4
- Conditions
- Progesterone Primed Endometrial Protocol, Gonadotropin Releasing Hormone Antagonist Protocol, Assisted Reproductive Treatments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 Mar 2024 (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 was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments.
Detailed description
Utilizing the assisted reproductive techniques (ART) has exhibited a substantial rise within the last years, emerging as a crucial modern medicine component with reliable results.
The utilized protocols for endometrial preparation in ART are aimed at maximizing the treatments' success. Typically, utilizing gonadotropin-stimulating hormone (GnRH) antagonists or agonists remains involved for preventing an early luteinizing hormone (LH) peak along ovulation prior to oocytes retrieval.
The GnRH-antagonist (GnRH-a) protocol is favored by many clinicians as well as patients due to its simplicity, convenience, flexibility, and absence of functional ovarian cysts or "menopausal" symptoms linked to the agonist protocol. Nevertheless, some RCTs' findings address that the antagonist protocol yields a reduced oocytes' number. Additionally, it exhibits lower pregnancy rates as opposed to the agonist extended therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone primed endometrial protocol | Active comparator | Other: Progesterone primed endometrial protocolThe cases were received soft progesterone capsules (brand name: Utrogestan, 100 mg, Laboratories Besins International, France) 100 mg and 150 IU of human menopausal gonadotropin (hMG) concomitantly from the menstrual cycle (MC) day 3 until the trigger day |
| Gonadotropin-releasing hormone antagonist protocol | Experimental | Other: Gonadotropin-releasing hormone antagonist protocolThe cases were received the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol consisting of HMG 150 IU's daily injection from MC 3 until the trigger day. GnRH-ant (Cetrotide, 0.25 mg, MerckSerono) was started when at least one of the following criteria were met: LH >10 IU/L, the presence of at least one follicle with mean diameter >14 mm, or serum E2 level >600 pg/mL. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 21 to 40 years.
- A basal antral follicle count (AFC) <6.
- All patients had to have a body mass index between 18.5 to 29.9 kg/m2.
- Undergoing IVF/ICSI cycles.
- With previous poor response to conventional prolonged therapy utilizing GnRH agonists (retrieving three oocytes).
Key exclusion criteria (6 listed)
- Cycles with fresh embryo transfer.
- Transfers of cleavage embryos (d2/d3).
- Embryos from cycles with preimplantation genetic screening.
- Cryopreservation of oocytes.
- Oocyte donation cycles.
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 |
|---|---|---|
| Progesterone primed endometrial protocolThe cases were received soft progesterone capsules (brand name: Utrogestan, 100 mg, Laboratories Besins International, France) 100 mg and 150 IU of human menopausal gonadotropin (hMG) concomitantly from the menstrual cycle (MC) day 3 until the trigger day. | Other | Progesterone primed endometrial protocol |
| Gonadotropin-releasing hormone antagonist protocolThe cases were received the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol consisting of HMG 150 IU's daily injection from MC 3 until the trigger day. GnRH-ant (Cetrotide, 0.25 mg, MerckSerono) was started when at least one of the following criteria were met: LH >10 IU/L, the presence of at least one follicle with mean diameter >14 mm, or serum E2 level >600 pg/mL. | Other | Gonadotropin-releasing hormone antagonist protocol |
Primary outcome
The number of retrieved oocytes
Time frame: 34 to 36 hours post HCG administration
Retrieved oocytes will be collected after ovarian induction by gonadotropin injection
1 secondary outcome
Pregnancy rate
Time frame: Fourteen days following the transfer
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 7 Mar 2024.
- 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.
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 Progesterone primed endometrial protocol and Gonadotropin-releasing hormone antagonist protocol in people with Progesterone Primed Endometrial Protocol and Gonadotropin Releasing Hormone Antagonist Protocol, run by New Valley 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 5 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: finished, as of the sponsor's last update on 7 Mar 2024. 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: 34 to 36 hours post HCG administration). 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 7 Mar 2024.