Progesterone Luteal Support in ICSIPhase 4NCT03040830
Effect of Timing Progesterone Luteal Support on Embryo Transfer
A Phase 4 study testing Progesterone 100 IM/day in people with Progesterone Luteal Support in ICSI and Embryo Transfer, run by Mansoura Integrated Fertility Center.
Trial summary
The study aims to know whether starting progesterone luteal support in intra cytoplasmic sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of embryo transfer compared with starting luteal support on day of embryo transfer Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Progesterone Luteal Support in ICSI, Embryo Transfer
- What is being tested?
- Progesterone 100 IM/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 1 Jan 2017
- 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
- first ICSI trial, normal uterus, normal cervix, normal ovarian response ,easy mock transfer,patient consenting
Who cannot join
- age over 38, difficult mock transfer, low and high ovarian response, patient not consenting
About this study
Official title: Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?
The study aims to know whether starting progesterone luteal support in intra cytoplasmic sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of embryo transfer compared with starting luteal support on day of embryo transfer
Read the detailed description
Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded of the allocation group.
A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm II (66) starting the same P4 dose on day of embryo transfer
- Being tested
- Progesterone 100 IM/day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone 100 IM/dayDrug
Progesterone IM 100 mg /day was started on day of egg retrieval in egg retrieval arm and on day of embryo transfer in the embryo transfer arm
| Study group | Role | What they receive |
|---|---|---|
| Egg retrieval arm | Experimental | 67 ICSI cases are started daily 100 mg IM prontogest on the day of egg retrieval until the day of pregnancy test. Receives: Drug: Progesterone 100 IM/day |
| Embryo transfer arm | Active comparator | 66 ICSI cases are started daily 100 mg IM prontogest on the day of embryo transfer until the day of pregnancy test. Receives: Drug: Progesterone 100 IM/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
difficult embryo transfer
presence of blood on embryo transfer catheter and or need for sounding or dilating the cervix to pass the embryo transfer catheter to the endometrial cavity
Measured: 3 minutes
Secondary outcomes (1)
cycle outcome
clinical cycle pregnancy rate calculated as number of clinical pregnancies (gestational sacs shown by ultrasound ) per 100 cases transferred multiplied by 100.Implantation rate calculated by the outcome of dividing the total number of gestational sacs in the arm by the total number of embryos transferred.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Nov 2015
- Primary completion30 Oct 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Progesterone Luteal Support in ICSIStudies 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
- Model description
- Double blind Randomized Controlled Trial : the clinicians and the patents were blinded of the allocation group. A total of 137 embryo transfers (ETs) were randomly allocated into either group A (67 ) starting luteal support as daily intra muscular (IM) injections of 100 mg prontogest on day of egg retrieval, or group B (66) starting the same P4 dose on day of embryo transfer.Transfer technique was blind tactile using Labotect catheter and was considered difficult if the inner ET catheter was blood stained and /or sounding or dilating the cervix was needed. Cervical traction or blood staining of outer sheath did not indicate difficulty
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura Integrated Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Elsaid Ghanem, Mansoura Integrated Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040830
- Sponsor's protocol ID
- P4 luteal support and ET
- Status last verified
- Jan 2017
- First submitted
- 30 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mochtar MH, Van Wely M, Van der Veen F. Timing luteal phase support in GnRH agonist down-regulated IVF/embryo transfer cycles. Hum Reprod. 2006 Apr;21(4):905-8. doi: 10.1093/humrep/dei437. Epub 2005 Dec 22.
PubMed 16373409Senciboy D.N and Sharpe-Timms K.L: Progesterone affects the cervix prior to embryo transfer. , Fertility and Sterility ,2001: 76 , Issue 3 , S220 - S221
Ghanem ME, Ragab AE, Alboghdady LA, Helal AS, Bedairy MH, Bahlol IA, Abdelaziz A. Difficult embryo transfer (ET) components and cycle outcome. Which is more harmful?. Middle East Fertility Society Journal. 2016 Jun 30;21(2):114-119
Ghanem ME, Bedairy MH, Shaaban A, Albahlol IA. Does the Time of Starting Progesterone Luteal Support Affect Embryo Transfer in Long Agonist Protocol Downregulated ICSI Cycles? A Randomized Controlled Trial. Reprod Sci. 2021 Mar;28(3):897-903. doi: 10.1007/s43032-020-00309-0. Epub 2020 Sep 9.
PubMed 32909190
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?
- ClinicalTrials.gov ID
- NCT03040830
- Acronym / sponsor ID
- P4 luteal support and ET
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mansoura Integrated Fertility CenterUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 2 Feb 2017 (estimated)
- 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 study aims to know whether starting progesterone luteal support in intra cytoplasmic sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of embryo transfer compared with starting luteal support on day of embryo transfer
Detailed description
Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded of the allocation group.
A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm II (66) starting the same P4 dose on day of embryo transfer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double blind Randomized Controlled Trial : the clinicians and the patents were blinded of the allocation group. A total of 137 embryo transfers (ETs) were randomly allocated into either group A (67 ) starting luteal support as daily intra muscular (IM) injections of 100 mg prontogest on day of egg retrieval, or group B (66) starting the same P4 dose on day of embryo transfer.Transfer technique was blind tactile using Labotect catheter and was considered difficult if the inner ET catheter was blood stained and /or sounding or dilating the cervix was needed. Cervical traction or blood staining of outer sheath did not indicate difficulty
| Arm | Type | Receives |
|---|---|---|
| Egg retrieval arm | Experimental | Drug: Progesterone 100 IM/day67 ICSI cases are started daily 100 mg IM prontogest on the day of egg retrieval until the day of pregnancy test. |
| Embryo transfer arm | Active comparator | Drug: Progesterone 100 IM/day66 ICSI cases are started daily 100 mg IM prontogest on the day of embryo transfer until the day of pregnancy test. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first ICSI trial, normal uterus, normal cervix, normal ovarian response ,easy mock transfer,patient consenting
Key exclusion criteria (1 listed)
- age over 38, difficult mock transfer, low and high ovarian response, patient not consenting
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 100 IM/dayProgesterone IM 100 mg /day was started on day of egg retrieval in egg retrieval arm and on day of embryo transfer in the embryo transfer arm | Drug | Egg retrieval arm, Embryo transfer arm |
Primary outcome
difficult embryo transfer
Time frame: 3 minutes
presence of blood on embryo transfer catheter and or need for sounding or dilating the cervix to pass the embryo transfer catheter to the endometrial cavity
1 secondary outcome
cycle outcome
Time frame: 4 weeks
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 2 Feb 2017.
- Background: PubMed 16373409Mochtar MH, Van Wely M, Van der Veen F. Timing luteal phase support in GnRH agonist down-regulated IVF/embryo transfer cycles. Hum Reprod. 2006 Apr;21(4):905-8. doi: 10.1093/humrep/dei437. Epub 2005 Dec 22.
- BackgroundSenciboy D.N and Sharpe-Timms K.L: Progesterone affects the cervix prior to embryo transfer. , Fertility and Sterility ,2001: 76 , Issue 3 , S220 - S221
- BackgroundGhanem ME, Ragab AE, Alboghdady LA, Helal AS, Bedairy MH, Bahlol IA, Abdelaziz A. Difficult embryo transfer (ET) components and cycle outcome. Which is more harmful?. Middle East Fertility Society Journal. 2016 Jun 30;21(2):114-119
- Derived from this study: PubMed 32909190Ghanem ME, Bedairy MH, Shaaban A, Albahlol IA. Does the Time of Starting Progesterone Luteal Support Affect Embryo Transfer in Long Agonist Protocol Downregulated ICSI Cycles? A Randomized Controlled Trial. Reprod Sci. 2021 Mar;28(3):897-903. doi: 10.1007/s43032-020-00309-0. Epub 2020 Sep 9.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone 100 IM/day in people with Progesterone Luteal Support in ICSI and Embryo Transfer, run by Mansoura Integrated Fertility Center.
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 1 inclusion and 1 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
difficult embryo transfer (time frame: 3 minutes). 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 NCT03040830, which also lists 4 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 2 Feb 2017.