Recombinant LH Prior to Ovarian Stimulation in Poor Ovarian Responders (PRE-LH) (NCT03741699) | Clinical Trial Compass
CompletedPhase 3
Recombinant LH Prior to Ovarian Stimulation in Poor Ovarian Responders (PRE-LH)
Spain88 participantsStarted 2019-02-18
Plain-language summary
Controlled ovarian stimulation (COS) is one of the first stages of assisted reproductive treatment. The goal is to mimic the ovarian cycle while stimulating the ovaries to overproduce eggs capable of being fertilized, thus maximizing the chances of reproductive success. The stimulation phase involves the use of different hormonal medications but requires tests to check the development of follicles, and hormonal adjustment to get the optimal ovarian response to stimulation.
However, between 9 to 24% of patients fail to respond adequately to standard stimulation protocols, resulting in Poor Ovarian Response (POR). In addition to the low oocyte production, POR results in a restricted number of good quality embryos with appropriate implantation potential, suggesting a compromised oocyte quality.
POR is one of the most challenging problems in reproductive medicine. Poor responders are difficult to treat since their response to stimulation tend to be deficient even when using different drugs or protocols. In recent years, different therapeutic alternatives have been proposed for these patients. However, to date, the optimal stimulation protocol has not yet been described and oocyte donation is often offered as their only option to achieve pregnancy.
Recently, evidence has emerged that supplementation with a specific hormone, luteinizing hormone (LH), during or prior to COS could lead to improved reproductive outcomes in poor responders by increasing the number of oocytes retrieved and improving their quality.
The present study aims to evaluate the effect of the treatment with LH prior to COS on the ovarian response in patients with POR and advanced maternal age, the worst prognosis but more frequent group of poor responders attending fertility clinics. We will assess whether LH treatment prior to COS increases the number and quality of oocytes retrieved in those patients and, finally, analyse the impact in their chances of getting pregnant and having a baby.
Who can participate
Age range35 Years – 43 Years
SexFEMALE
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Inclusion criteria
✓. -Patients with POR according to specific criteria that are in line with the criteria defined by the ESHRE (Bologna Criteria), according to which a patient is classified as a poor ovarian responder when she meets two of the three of the following criteria: I.- Previous episode of POR (≤3 oocytes) with conventional stimulation protocol II.- Abnormal ovarian reserve test with an antral follicle count (AFC) \<5-7 and/or anti-mullerian hormone values (AMH) \<0.5-1.1 ng/mL.
✓. \- Women ≥35 to ≤43 years for COS and assisted reproduction techniques (ART).
✓. \- Couple or single woman, accepting preimplantation genetic diagnosis (PGS) after blastocyst biopsy and delayed transfer for selection of euploid embryos.
✓. \- Body Mass Index (BMI) between18 and 30 kg/m 2 , inclusive.
✓. \- Ejaculatory sperm with concentration ≥ 5 mill spermatozoa/mL and ≥ 5 mill total spermatozoa progressive motility. Bank and cryopreserved semen allowed.
✓. \- Informed consent completed, signed and dated.
Exclusion criteria
✕. \- Cases of recurrent spontaneous miscarriage (≥2 clinical miscarriages) or implantation failure (after transfer of 6 good D3 embryos or 4 good blastocysts) will be excluded.
What they're measuring
1
number of oocytes retrieved
Timeframe: 37 days
Trial details
NCT IDNCT03741699
SponsorInstituto Valenciano de Infertilidad, IVI Alicante
✕. \- Use of testicular or epididymal spermatozoa as well as ejaculate with concentration \< 5 mill spermatozoa/mL and \< 5 mill total spermatozoa progressive motility.
✕. \- Primary ovarian failure, PCOS (in accordance with the Rotterdam criteria) or ovary/s inaccessible for oocyte retrieval.
✕. \- Anatomical uterine abnormalities and any endometrium or myometrium pathology (adenomyosis, polyps, myoma, etc.) that may interfere with implantation or pregnancy. Patients with previous polypectomy, myomectomy or surgery for septate/subseptate/arcuatus uterus should not be excluded.
✕. \- Presence of unilateral or bilateral hydrosalpinx that has not been surgically removed or ligated.
✕. \- Presence of level III-IV endometriosis.
✕. \- History of tumours in the hypothalamus or pituitary gland, or ovarian, uterine or breast cancer.