In Vitro FertilizationPhase 4NCT04727684

Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

A Phase 4 study testing Triptorelin acetate, Cetrorelix and recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin in people with In Vitro Fertilization and Infertility, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 39 years, women only
Conditions the study is for: In Vitro Fertilization, Infertility, Intracytoplasmic Sperm Injection
What is being tested?: Triptorelin acetate, Cetrorelix and recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteSyria
Study dates: 22 Aug 2020to 12 May 2022
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 39 years
Women only
No healthy volunteers
Adult

Who may be able to join

PCOS women undergoing IVF/ICSI.
Age: 18-39 years.
Both ovaries present.

Who cannot join

Age ≥ 40 years.
History of three or more previous IVF failures.
Patients with hormonal disorders like hyperprolactinemia, thyroid disorders.
Patients who previously undergo Unilateral Oophorectomy.
Patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases.
Patients with diseases may affect IVF outcomes: Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases,
Cancer.

Trial locations and contacts

1 site in 1 country.

Syria1 site

Orient Hospital
Damascus

Other trials in Syria

About this study

Official title: Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

Selection of developmentally competent oocytes enhances IVF efficiency. Usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features. Gonadotropin-releasing hormone agonists (GnRH Agonists) and gonadotropin-releasing hormone antagonists (GnRH Antagonists) are used during controlled ovarian stimulation (COS) protocols in order to prevent premature luteinizing hormone (LH) surge and premature ovulation. However, GnRH receptors are also expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type of GnRH analogues used during COS could affect the oocyte morphology in polycystic ovary syndrome (PCOS) patients. The aim of this prospective, non-randomised, open-label, clinical trial is to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology in PCOS patients during IVF/ICSI.

Conditions: In Vitro Fertilization, Infertility, Intracytoplasmic Sperm Injection, Polycystic Ovary Syndrome
Being tested: Triptorelin acetate, Cetrorelix, recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin, Human Chorionic Gonadotropin (hCG)
Keywords: GnRH Agonist, GnRH Antagonist, Oocyte morphology, Assisted reproduction technique, In Vitro Fertilization, Intracytoplasmic sperm injection, Polycystic Ovary Syndrome
Medical subject headings: Infertility, Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triptorelin acetateDrug
0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.
CetrorelixDrug
0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.
recombinant-FSH or recombinant-FSH + human Menopausal GonadotropinDrug
Dosage adjustment according to the ovarian response.
Human Chorionic Gonadotropin (hCG)Drug
Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.

Study groups in NCT04727684
Study group	Role	What they receive
Agonist Group (long protocol):	Active comparator	The pituitary down-regulation in this group will be carried out using 0.05-0.1 mg of Triptorelin acetate subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the menstrual cycle until the ovulation triggering day. When the suppressive effect is obtained, ovarian stimulation will commence with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) and the dose will be adjusted according to the ovarian response. Ovulation will be triggered by the administration of 10,000 IU of human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI). Receives: Drug: Triptorelin acetate; Drug: recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin; Drug: Human Chorionic Gonadotropin (hCG)
Antagonist Group (Flexible protocol):	Experimental	The ovarian stimulation in this group will be started with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) on the third day of the menstrual cycle and the dose will be adjusted according to the ovarian response. Initiation of 0.25 mg of GnRH antagonist; Cetrorelix; will take place after detecting a leading follicle diameter ≥ 14 mm. GnRH antagonist administration will be continued till the day of ovulation triggering, which will be accomplished by given 10,000 IU of human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI). Receives: Drug: Cetrorelix; Drug: recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin; Drug: Human Chorionic Gonadotropin (hCG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of oocyte dysmorphisms among the studied groups:
Before being subjected to ICSI, the oocytes from both groups will be morphologically analyzed under an inverted microscope; Nikon Eclipse Ti2; in order to detect cytoplasmic and extra-cytoplasmic dysmorphisms.
Measured: Before oocytes microinjection

Secondary outcomes (12)

Number of oocytes retrieved:
The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration 35±2 hours after hCG administration.
Measured: Immediately after oocyte retrieval (35±2 hours after hCG administration)
Number of Metaphase II Oocytes (MII):
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Measured: Within two hours after oocyte retrieval
Number of Metaphase I Oocytes (MI):
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Measured: Within two hours after oocyte retrieval
Number of Germinal Vesicle Oocytes (GV):
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Measured: Within two hours after oocyte retrieval
Number of Atretic Oocytes:
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Measured: Within two hours after oocyte retrieval
Maturation Rate%:
Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes.
Measured: Within two hours after oocyte retrieval
Fertilization Rate%:
Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes.
Measured: 16-18 hours after microinjection
Cleavage Rate%:
Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN).
Measured: Day 2 after microinjection
Embryo Quality:
Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011).
Measured: Day of transfer (2 or 3 days after microinjection)
High Quality Embryos rate%:
High Quality Embryos rate is calculated by dividing the number of high quality embryos (Grade I) by the total number of cleavaged embryos.
Measured: Day of transfer (2 or 3 days after microinjection)
Biochemical Pregnancy Rate% (Per Embryo Transfer):
Biochemical pregnancy is defined as a positive serum beta-hCG pregnancy test after 2 weeks of embryo transfer. The biochemical pregnancy rate is calculated by dividing the number of women who are biochemically pregnant by the number of women who have at least 1 embryo transferred.
Measured: 2 weeks after embryo transfer
Clinical Pregnancy Rate% (Per Embryo Transfer):
Clinical pregnancy is defined as the presence of a gestational sac on ultrasound after 3-4 weeks of embryo transfer. The clinical pregnancy rate is calculated as by dividing the number of women who are clinically pregnant divided by the number of women who have at least 1 embryo transferred.
Measured: 3-4 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 202012 May 2022

First posted27 Jan 2021
Study start22 Aug 2020
Primary completion15 Feb 2022
Study completion12 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for In Vitro FertilizationStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04727684
Sponsor's protocol ID: Ph-CT-4300
Status last verified: Oct 2023
First submitted: 18 Jan 2021
Last updated: 24 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57.
PubMed 27510637
Dennett CC, Simon J. The role of polycystic ovary syndrome in reproductive and metabolic health: overview and approaches for treatment. Diabetes Spectr. 2015 May;28(2):116-20. doi: 10.2337/diaspect.28.2.116. No abstract available.
PubMed 25987810
Aguilar-Rojas A, Huerta-Reyes M. Human gonadotropin-releasing hormone receptor-activated cellular functions and signaling pathways in extra-pituitary tissues and cancer cells (Review). Oncol Rep. 2009 Nov;22(5):981-90. doi: 10.3892/or_00000525.
PubMed 19787210
Cheung LW, Wong AS. Gonadotropin-releasing hormone: GnRH receptor signaling in extrapituitary tissues. FEBS J. 2008 Nov;275(22):5479-95. doi: 10.1111/j.1742-4658.2008.06677.x.
PubMed 18959738
Setti AS, Figueira RC, de Almeida Ferreira Braga DP, Azevedo MC, Iaconelli A Jr, Borges E Jr. Oocytes with smooth endoplasmic reticulum clusters originate blastocysts with impaired implantation potential. Fertil Steril. 2016 Dec;106(7):1718-1724. doi: 10.1016/j.fertnstert.2016.09.006. Epub 2016 Oct 12.
PubMed 27743693
Sfontouris IA, Lainas GT, Lainas TG, Faros E, Banti M, Kardara K, Anagnostopoulou K, Kontos H, Petsas GK, Kolibianakis EM. Complex chromosomal aberrations in a fetus originating from oocytes with smooth endoplasmic reticulum (SER) aggregates. Syst Biol Reprod Med. 2018 Aug;64(4):283-290. doi: 10.1080/19396368.2018.1466375. Epub 2018 May 2.
PubMed 29718716
Stigliani S, Moretti S, Casciano I, Canepa P, Remorgida V, Anserini P, Scaruffi P. Presence of aggregates of smooth endoplasmic reticulum in MII oocytes affects oocyte competence: molecular-based evidence. Mol Hum Reprod. 2018 Jun 1;24(6):310-317. doi: 10.1093/molehr/gay018.
PubMed 29635518
Setti AS, Figueira RC, Braga DP, Colturato SS, Iaconelli A Jr, Borges E Jr. Relationship between oocyte abnormal morphology and intracytoplasmic sperm injection outcomes: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Dec;159(2):364-70. doi: 10.1016/j.ejogrb.2011.07.031. Epub 2011 Aug 6.
PubMed 21824710
Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.
PubMed 26630267
Wissing ML, Bjerge MR, Olesen AI, Hoest T, Mikkelsen AL. Impact of PCOS on early embryo cleavage kinetics. Reprod Biomed Online. 2014 Apr;28(4):508-14. doi: 10.1016/j.rbmo.2013.11.017. Epub 2013 Dec 17.
PubMed 24581983
Cota AM, Oliveira JB, Petersen CG, Mauri AL, Massaro FC, Silva LF, Nicoletti A, Cavagna M, Baruffi RL, Franco JG Jr. GnRH agonist versus GnRH antagonist in assisted reproduction cycles: oocyte morphology. Reprod Biol Endocrinol. 2012 Apr 27;10:33. doi: 10.1186/1477-7827-10-33.
PubMed 22540993
Zanetti BF, Braga DPAF, Setti AS, Iaconelli A Jr, Borges E Jr. Effect of GnRH analogues for pituitary suppression on oocyte morphology in repeated ovarian stimulation cycles. JBRA Assist Reprod. 2020 Jan 30;24(1):24-29. doi: 10.5935/1518-0557.20190050.
PubMed 31436072
Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
PubMed 14711538
Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.
PubMed 21502182

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
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All In Vitro Fertilization trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI
ClinicalTrials.gov ID: NCT04727684
Acronym / sponsor ID: Ph-CT-4300
Conditions: In Vitro Fertilization, Infertility, Intracytoplasmic Sperm Injection, Polycystic Ovary Syndrome
Keywords: GnRH Agonist, GnRH Antagonist, Oocyte morphology, Assisted reproduction technique, In Vitro Fertilization, Intracytoplasmic sperm injection, Polycystic Ovary Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 22 Aug 2020 (actual)
Primary completion: 15 Feb 2022 (actual)
Study completion: 12 May 2022 (actual)
First posted: 27 Jan 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Agonist Group (long protocol):	Active comparator	Drug: Triptorelin acetate, Drug: recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin, Drug: Human Chorionic Gonadotropin (hCG)The pituitary down-regulation in this group will be carried out using 0.05-0.1 mg of Triptorelin acetate subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the menstrual cycle until the ovulation triggering day. When the suppressive effect is obtained, ovarian stimulation will commence with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) and the dose will be adjusted according to the ovarian response. Ovulation will be triggered by the administration of 10,000 IU of human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).
Antagonist Group (Flexible protocol):	Experimental	Drug: Cetrorelix, Drug: recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin, Drug: Human Chorionic Gonadotropin (hCG)The ovarian stimulation in this group will be started with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) on the third day of the menstrual cycle and the dose will be adjusted according to the ovarian response. Initiation of 0.25 mg of GnRH antagonist; Cetrorelix; will take place after detecting a leading follicle diameter ≥ 14 mm. GnRH antagonist administration will be continued till the day of ovulation triggering, which will be accomplished by given 10,000 IU of human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

PCOS women undergoing IVF/ICSI.
Age: 18-39 years.
Both ovaries present.

Key exclusion criteria (7 listed)

Age ≥ 40 years.
History of three or more previous IVF failures.
Patients with hormonal disorders like hyperprolactinemia, thyroid disorders.
Patients who previously undergo Unilateral Oophorectomy.
Patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases.

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
Triptorelin acetate0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.	Drug	Agonist Group (long protocol):
Cetrorelix0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.	Drug	Antagonist Group (Flexible protocol):
recombinant-FSH or recombinant-FSH + human Menopausal GonadotropinDosage adjustment according to the ovarian response.	Drug	Agonist Group (long protocol):, Antagonist Group (Flexible protocol):
Human Chorionic Gonadotropin (hCG)Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.	Drug	Agonist Group (long protocol):, Antagonist Group (Flexible protocol):

Primary outcome

Prevalence of oocyte dysmorphisms among the studied groups:
Time frame: Before oocytes microinjection
Before being subjected to ICSI, the oocytes from both groups will be morphologically analyzed under an inverted microscope; Nikon Eclipse Ti2; in order to detect cytoplasmic and extra-cytoplasmic dysmorphisms.

12 secondary outcomes

Number of oocytes retrieved:
Time frame: Immediately after oocyte retrieval (35±2 hours after hCG administration)
Number of Metaphase II Oocytes (MII):
Time frame: Within two hours after oocyte retrieval
Number of Metaphase I Oocytes (MI):
Time frame: Within two hours after oocyte retrieval
Number of Germinal Vesicle Oocytes (GV):
Time frame: Within two hours after oocyte retrieval
Number of Atretic Oocytes:
Time frame: Within two hours after oocyte retrieval
Maturation Rate%:
Time frame: Within two hours after oocyte retrieval
Fertilization Rate%:
Time frame: 16-18 hours after microinjection
Cleavage Rate%:
Time frame: Day 2 after microinjection
Embryo Quality:
Time frame: Day of transfer (2 or 3 days after microinjection)
High Quality Embryos rate%:
Time frame: Day of transfer (2 or 3 days after microinjection)
Biochemical Pregnancy Rate% (Per Embryo Transfer):
Time frame: 2 weeks after embryo transfer
Clinical Pregnancy Rate% (Per Embryo Transfer):
Time frame: 3-4 weeks after embryo 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 24 Oct 2023.
Background: PubMed 27510637Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57.
Background: PubMed 25987810Dennett CC, Simon J. The role of polycystic ovary syndrome in reproductive and metabolic health: overview and approaches for treatment. Diabetes Spectr. 2015 May;28(2):116-20. doi: 10.2337/diaspect.28.2.116. No abstract available.
Background: PubMed 19787210Aguilar-Rojas A, Huerta-Reyes M. Human gonadotropin-releasing hormone receptor-activated cellular functions and signaling pathways in extra-pituitary tissues and cancer cells (Review). Oncol Rep. 2009 Nov;22(5):981-90. doi: 10.3892/or_00000525.
Background: PubMed 18959738Cheung LW, Wong AS. Gonadotropin-releasing hormone: GnRH receptor signaling in extrapituitary tissues. FEBS J. 2008 Nov;275(22):5479-95. doi: 10.1111/j.1742-4658.2008.06677.x.
Background: PubMed 27743693Setti AS, Figueira RC, de Almeida Ferreira Braga DP, Azevedo MC, Iaconelli A Jr, Borges E Jr. Oocytes with smooth endoplasmic reticulum clusters originate blastocysts with impaired implantation potential. Fertil Steril. 2016 Dec;106(7):1718-1724. doi: 10.1016/j.fertnstert.2016.09.006. Epub 2016 Oct 12.
Background: PubMed 29718716Sfontouris IA, Lainas GT, Lainas TG, Faros E, Banti M, Kardara K, Anagnostopoulou K, Kontos H, Petsas GK, Kolibianakis EM. Complex chromosomal aberrations in a fetus originating from oocytes with smooth endoplasmic reticulum (SER) aggregates. Syst Biol Reprod Med. 2018 Aug;64(4):283-290. doi: 10.1080/19396368.2018.1466375. Epub 2018 May 2.
Background: PubMed 29635518Stigliani S, Moretti S, Casciano I, Canepa P, Remorgida V, Anserini P, Scaruffi P. Presence of aggregates of smooth endoplasmic reticulum in MII oocytes affects oocyte competence: molecular-based evidence. Mol Hum Reprod. 2018 Jun 1;24(6):310-317. doi: 10.1093/molehr/gay018.
Background: PubMed 21824710Setti AS, Figueira RC, Braga DP, Colturato SS, Iaconelli A Jr, Borges E Jr. Relationship between oocyte abnormal morphology and intracytoplasmic sperm injection outcomes: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Dec;159(2):364-70. doi: 10.1016/j.ejogrb.2011.07.031. Epub 2011 Aug 6.
Background: PubMed 26630267Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.
Background: PubMed 24581983Wissing ML, Bjerge MR, Olesen AI, Hoest T, Mikkelsen AL. Impact of PCOS on early embryo cleavage kinetics. Reprod Biomed Online. 2014 Apr;28(4):508-14. doi: 10.1016/j.rbmo.2013.11.017. Epub 2013 Dec 17.
Background: PubMed 22540993Cota AM, Oliveira JB, Petersen CG, Mauri AL, Massaro FC, Silva LF, Nicoletti A, Cavagna M, Baruffi RL, Franco JG Jr. GnRH agonist versus GnRH antagonist in assisted reproduction cycles: oocyte morphology. Reprod Biol Endocrinol. 2012 Apr 27;10:33. doi: 10.1186/1477-7827-10-33.
Background: PubMed 31436072Zanetti BF, Braga DPAF, Setti AS, Iaconelli A Jr, Borges E Jr. Effect of GnRH analogues for pituitary suppression on oocyte morphology in repeated ovarian stimulation cycles. JBRA Assist Reprod. 2020 Jan 30;24(1):24-29. doi: 10.5935/1518-0557.20190050.

Related trials for In Vitro Fertilization

RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF

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.

Sally Kadoura, B Pharm, MD principal investigator

Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

Abdul Hakim Nattouf, MD, PhD study director

Professor at Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

Marwan Alhalabi, MD, PhD study director

Professor at Department of Embryology and Reproductive Medicine, Faculty of Medicine, Damascus University, Damascus, Syria.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 24 Oct 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 Syria. 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?

Prevalence of oocyte dysmorphisms among the studied groups: (time frame: Before oocytes microinjection). 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 NCT04727684, which also lists 14 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 24 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.