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withdrawn due to practical reasons
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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This is a prospective randomized open-label cross-over study. Poor responder patients will undergo two ovarian stimulation cycles. One with recombinant follicle stimulation hormone (FSH), and an other stimulation with recombinant FSH and recombinant luteinizing hormone (LH). In both groups, a freeze-all strategy will be applied and an endometrial biopsy will be taken 7 days after final oocyte maturation trigger. Endometrial gene expression analysis will be performed on both biopsies. After completion of both treatment cycles, a frozen embryo transfer of a single embryo will be performed.
This is a prospective randomized open-label cross-over study, in which patients will be randomized to either start in the control group or in the study group. Participants will undergo both treatments with an interval of minimum 1 and maximum 6 months. In both treatment arms, ovarian stimulation will be started at day 2/3 of the menstrual cycle. In the control group, 225 IU of recombinant FSH will be administered in a fixed antagonist protocol. In the study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered. Cycle monitoring will be performed through serum estradiol (E2), progesterone (P), and luteinizing hormone (LH) assessments, combined with serial ultrasound examinations. Both groups will undergo dual triggering with gonadotropin releasing hormone agonist (GnRHa) 0,2ml and human chorionic gonadotrophin (hCG) 6500IU if one or more follicles of ≥ 17 mm are observed. The oocyte retrieval (OR) will be performed between 34 and 36 hours after final oocyte maturation trigger. At each OR, follicles will be individually meas-ured, aspirated and searched for the presence of cumulus oocyte complexes (COC). Metaphase II (MII) oocytes will then be injected to standard intra-cytoplasmatic sperm injection (ICSI) procedures. In both groups, a freeze-all strategy will be applied. An endometrial biopsy (Pipelle de Cornier ®) will be taken 7 days after final oocyte maturation trigger. After completion of both treatment cycles, a frozen embryo transfer of a single embryo will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Active Comparator | In the control group, 225 IU of recombinant FSH will be administered in a fixed antagonist protocol. |
|
| Study arm | Experimental | In the study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutropin alfa | Drug | addition of recombinant luteinizing hormone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| endometrial gene expression | gene expression profile of the endometrium | 7 days after finale oocyte maturation trigger |
| Measure | Description | Time Frame |
|---|---|---|
| cumulus cell gene expression | 3-6 months | |
| endometrial histologic analysis based on Noyes' classification system | 3-6 months | |
| progesterone level at oocyte triggering |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Blockeel | UZ Brussels | Principal Investigator |
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| ID | Term |
|---|---|
| D037101 | Luteinizing Hormone, beta Subunit |
| C571801 | follitropin alfa |
| ID | Term |
|---|---|
| D007986 | Luteinizing Hormone |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
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prospective randomized open-label cross-over study
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| Follitropin alfa |
| Drug |
recombinant follicle stimulating hormone (FSH) |
|
| Endometrial biopsy | Diagnostic Test | pipelle de cornier biopsy |
|
| 3-6 months |
| follicular fluid (FF) hormonal analysis | 3-6 months |
| number of preovulatory follicles | 3-6 months |
| number of MII oocytes | 3-6 months |
| number of oocytes fertilized | 3-6 months |
| number of good quality embryos | 3-6 months |
| total dose of gonadotropins administered | 3-6 months |
| duration of stimulation | 3-6 months |
| endometrial thickness at the day of endometrial biopsy | 3-6 months |
| implantation rate | 6-12 months |
| clinical pregnancy rate | 6-12 months |
| live birth rate | 20 months |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |